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Company

Title

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Sede: Aprilia (LT)
Modalità: prevalentemente on site, con possibilità di smart working una volta raggiunta una certa autonomia lavorativa
Tipologia di Contratto: tempo determinato di 6 mesi (in somministrazione con inquadramento C2 del CCNL Chimico - Farmaceutico)

Mansioni:

Coordinare, pianificare ed eseguire le attività di sviluppo e convalida dei processi di manifattura, confezionamento e cleaning;
Preparare e revisionare la documentazione necessaria allo svolgimento delle prove di sviluppo e convalida (protocolli / rapporti di sviluppo / convalida, istruzioni di manifattura, piani di campionamento, carte di controllo, Master Formula, ordini di produzione);
Aggiornare le SOP che regolano l’attività del reparto in linea con le linee guida aziendali;
Collaborare e supportare per l’ambito tecnologico le altre funzioni di nella valutazione e preparazione di documenti relativi all’assicurazione qualità;
Raccogliere ed elaborare i dati di processo e quelli provenienti dal quality control necessari alla stesura dei rapporti finali.

Titolo di Studio: Laurea magistrale in materie scientifiche quali Chimica, Chimica e Tecnologia Farmaceutiche o Biotecnologie.

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QC Analyst (Chemical Area)

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Location: Pomezia (RM)
Expected Travel: 0-10 %

Context:
The candidate will be introduced within the Quality Control and will report to the QC Manager. He/she will perform in-process and product analytical controls to support the GMP process manufacturing.
He/she will be involved in the execution of routine chemical testing to support production, stability program, and completing required documentation

Main activities and responsabilities:

Analyse samples following standard procedures effectively under minimal supervision within the scheduling communicated to him/her by QC manager and within the scope of pre-established or discussed objectives.
Carry out all laboratory operations in a safe manner and keep contemporary, accurate, legible records in accordance with GMP practices as well as all appropriate SOPs.
Provide support for:1) maintaining the quality of laboratories, by monitoring the state of cleanliness, order and physical condition; 2) verification of the presence of DPI, labels for toxic and harmful and correct storage; 3) verification of the calibration and maintenance status of the equipment; 4) control of the storage equipment and of materials and reagents by expiry dates, suitable storage and presence of MSDS

Routine testing:
• Perform tests (mainly spectroscopic and chromatographic techniques) in order to allow the efficient and reliable control of raw materials, APIs, intermediates and utilities (process water and pure steam condensate) in compliance with both procedures and programs;
• Conduct the chemical-physical and biochemical tests of the stability studies

Participate actively in the preparation of audit;
Write the procedures of the Chemical laboratory of its competence before their use;
Notify promptly any not compliance results to QC Manager and perform the initial investigation;
Through revision of performed laboratory operations;
Ensure that the CAPA assigned are carried out within the defined timeframe;
Maintain and monitor laboratory instruments and participate in qualification and calibration of equipment.

Job requirements:
Education

Bachelor’s degree Chemistry, Biochemistry or related field

Years of experience

At minimum 1 (one) year in quality control (Chemical Area) experience is preferred

Qualification and skills

Experience in Cromatography (HPLC and/or UPLC). Previous experience in Chromatographic Software EmpowerTM is requested. Knowledge of Capillary Electrophoresis AB Sciex PA800 is a plus.
Ability to apply concepts of basic statistics.
Ability to perform testing with written instructions.
Ability to accurately record and interpret data testing results.
Ability to identify problems, collect data, establish facts and draw valid conclusions.
He/she should be highly organized and detail-oriented.
He/she should demonstrate effective time management.
The candidate should have the ability to communicate and collaborate effectively within team and with members of other departments.
He/She should be able to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and records.
He/she should have the ability to work well with others in fast paced, dynamic environment.
He/she should be respectful, approachable and team oriented while building strong working relationships and a positive work environment.

Language skills and level of proficiency

English-Intermediate Level

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Informatore Scientifico del Farmaco

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Adecco Lifescience è alla ricerca, per un'importante azienda farmaceutica, di una figura di Informatore Scientifico del Farmaco che si occuperà di svolgere un'attività di informazione e consulenza scientifica verso i seguenti target medici: gastroenterologi, ginecologi, proctologi e urologi.

Responsabilità:

Sviluppo della zona assegnata in esclusiva Roma Centro e Roma Nord (Microarea 2,4,5,19,20);
Mantenimento di solidi e proficui rapporti con il target di riferimento (Gastroenterologia, Ginecologia, Proctologia e Urologia);
Training scientifico dei prodotti a listino presso il target Medico.

Requisiti:

Laurea ad indirizzo scientifico
Preferibile esperienza pregressa, ma si valutano anche profili neofiti
Ottime capacità organizzative
Ottime capacità comunicative e di ascolto
Automuniti

Si offre:

Inquadramento come Agente mono mandato Enasarco, condizioni economiche da valutare in base alla seniority e condizione di provenienza della risorsa scelta.
Gestione della zona in esclusiva.
Affiancamento iniziale, ed un percorso formativo costante e strutturato

Link all’annuncio Adecco: https://go0.it/agWab

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Senior EU QA Officer

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Location: Malta Office - APL Swift Services (Malta) Ltd, HF26, Hal Far Industrial Estate, Birzebbugia BBG 3000 Malta

Objectives:

Assists the European Quality Manager in the day-to-day operation and management of the quality system according to EU GxP requirements.
Assists the European Quality Manager in the upkeep of the Regulatory Compliance.
Maintenance and management of all GxP documentation pertaining to CMOs.
Coordinate the Quality Assurance Projects

Tasks and Responsibilities:
Support manager in the management of all CMO relations including:

Quality Management Systems such as Complaints, Deviations, PQR, Audits, Change Controls, TA’s and CAPA’s.
Reviewing of EU guidelines and determine the impact on the current systems or processes of Aurobindo.
Preparing the SOP’s.
Performing of audits on Supplier and European Aurobindo Affiliates.
Follow up on Supplier audits and qualification system.
Support EU Quality team in relation to EU GxP/ EMA requirements.
Overseeing Quality tracker Metrics of the European Aurobindo Affiliates.
Carry out other duties as required.

The ideal candidate must:

Have a minimum of 5-year experience within Pharmaceutical Company - QA department QMS

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Chemist

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Employer: Leo Pharma
Location: Ballerup (Denmark)
Contract: Permanent

Are you interested in joining our team at Quality Laboratories, which supports global stability studies?

Job description:
LEO Pharma has embarked on an ambitious journey to become the preferred dermatology care partner improving people’s lives around the world – and that is why we need you. We are looking for an experienced chemist who can take on and lead tasks related to projects, improvements, and stability operations. You will solve tasks by understanding the problems and contributing your expertise, along with the necessary input from other specialists in the department. As we conduct stability studies globally, you will have a broad interface with the rest of the organization in Denmark, France, Ireland, and Italy, as well as our CMOs around the world.

Task:
You will work as a technical specialist. The tasks include operational tasks such as design, execution, and reporting of stability studies, as well as Life Cycle Management projects and improvement projects, together with a team of chemists and laboratory technicians.

Design of stability studies and preparation of protocols in accordance with ICH and GMP
Trending of stability data and maintenance of trend reports
Preparation of GMP and PQR reports
Handling of OOS together with QC laboratories
Participation in development projects as a stability SME
Optimization of procedures and processes

Qualifications:
To succeed in this role, we imagine that you have the following qualifications:

You have a Master of Science in pharmacy, chemical engineering, or similar
You have several years of practical experience in product stability, analytical chemistry, and/or chemistry in the pharmaceutical industry, and you are solidly grounded in your field
You have some experience with ICH
You have solid experience with GMP
You have the business perspective to balance costs and risks in a pragmatic way.

Regardless of your background, you are outgoing and good at collaborating with others. You are self-driven, focused, and able to make decisions. You can communicate effectively in writing and speaking in English, and it is a requirement that you understand and can communicate in Danish/Scandinavian.

We work under GMP, so you must also have the necessary structure and attention to detail to ensure that things are in order.

Your new team:
You will be part of a team of about 7 people who support locally and globally, and you will work collaboratively across the organization. You will be part of our modern Quality Laboratories, where you will have about 65 colleagues who serve the entire organization. You will have flexible working hours that are adapted to the tasks at hand. Our environment is characterized by collaboration, openness, and the opportunity to have fun together. It is simply a nice place to be.

---

About the company:
At LEO Pharma, we help people with skin diseases live fulfilling lives by advancing dermatology beyond the skin. We drive dermatology with our knowledge, collaboration, and curiosity, and we are at the forefront of science in developing new medicines. For us, pioneering together is about constantly improving and extending what’s possible for each other, our company, and our patients.

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Technical Operations Junior Consultant

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Sede Latina (LT) - Lazio
Orario: Full Time con turnazione (Mattina/Pomeriggio/Notte)
Disponibilità: Immediata
Tipologia di contratto: L’inquadramento e il pacchetto retributivo saranno commisurati all’esperienza del/la candidato/a.

S4BT è un’Azienda di oltre 80 specialisti, che da oltre 25 anni fornisce soluzioni software e consulenze per il settore Life Science e non solo in ambito Qualità, Ingegneria, Project Management, Validazioni, Tech Transfer, CSV e altro.
A supporto della crescita aziendale, ricerchiamo un/una consulente che ricoprirà il ruolo di Technical Operations Junior Consultant per l’esecuzione di attività progettuali in ambito chimico-farmaceutico.

Responsabilità:

Stesura di documenti di convalida di cleaning e processo (protocolli, report, VMP);
Supervisione tecnica delle attività in campo su processi di manifattura (granulazione, compressione e filmatura compresse);
Supporto nelle attività inerenti a cleaning validation (revisione documenti, campionamenti ed attività in turno);
Capacità di intervenire, valutare e risolvere deviazioni o anomalie di processo, fornendo tempestivamente indicazioni e soluzioni;
Gestione delle attività documentali di supporto ai processi di convalida in campo e non (corretta compilazione dei documenti, esecuzione campionamenti, esecuzione IPC);
Capacità di estrazione/elaborazione statistica dei dati di processo finalizzata alla stesura dei report di convalida.

Cosa ci piace in un/a candidato/a:

prontezza, operativa e flessibilità;
un approccio consulenziale e collaborativo con i colleghi e con i clienti;
spiccate qualità di team player, capace di favorire confronti costruttivi e la condivisione di informazioni sia con i collaboratori interni che con i clienti o fornitori coinvolti nei progetti;
ottima capacità di gestire lo stress, mantenendo il controllo e il focus sulle priorità;
orientamento alla qualità.

Requisiti:

Esperienza minima di 6/12 mesi nella Cleaning e nella Process Validation, preferibilmente su Manifattura Solidi Orali;
Provenienza dal settore farmaceutico;
Laurea Triennale o Magistrale in materie tecnico-scientifiche (CTF, Farmacia, Chimica, Ingegneria Chimica);
Buona conoscenza della lingua inglese (livello min. B1).

Si offre: sistema di welfare, previdenza complementare aziendale, benefit, formazione continua, eventi.

Presenta il tuo cv alla nostra mail selezione@s4btsrl.com

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Quality Assurance Specialist

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Location: Latina Scalo (LT) - Lazio
Contract: 6 months of paid Internship

Main Activities:

Batch record review

Ensure compliance and completeness of the Batch record, through collection and analysis of all necessary documentation, documentary verification of material approval status, check list and current SOPs, in compliance with applicable regulations (laws, GMP regulations, FDA, etc.) and company quality standards.

Investigation Management

Support the supervisor in managing investigation of deviations and complaints, preparation of appropriate reporting, complete with corrective and preventive actions in compliance with company procedures.

Planning GMP Training

Ensure, through the coordination and control of the employee structure, efficient planning of training required by GMP standards towards all personnel, through analysis of training needs and coordination of the organizational needs of different functions, in compliance with GMP standards.

Quality

Ensure compliance with company quality standards, through the implementation of procedures related to areas of responsibility, in accordance with company quality policies and procedures.

Main Requirements:

MA degree (CTF/Chemistry, Pharmacy, Biology…)
Knowledge of GMP
English working knowledge
Great can-do attitude

At BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. We respect the diversity, the different backgrounds and experiences and provide equal opportunity for all. We are BSP!

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Educatori - varie sedi Italia

Ingegnere di Convalida - Latina

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Sede: Latina
Modalità: on site
Tipologia di Contratto: inserimento diretto a tempo indeterminato, livello e retribuzione commisurate alla reale esperienza del candidato, ottime opportunità di crescita professionale.

Mansioni:

Redigere i protocolli di qualifica di IQ-OQ-PQ degli equipment di produzione ed utilities;
Assicurare l'analisi e la valutazione della documentazione tecnica relativa agli impianti ed alle macchine che devono essere sottoposti a qualifica;
Assicurare la corretta qualifica degli impianti e macchinari attraverso l'esecuzione delle attività previste dai protocolli, ed il coordinamento e la supervisione delle attività svolte dalle altre funzioni nel rispetto delle procedure aziendali.

Completano il profilo:

L’esperienza di almeno 6 mesi in ruolo analogo;
Una buona conoscenza della lingua inglese sia scritta che parlata;
Una buona predisposizione al team working.

Titolo di Studio: Laurea magistrale in Ingegneria Chimica, Chimica e Tecnologie Farmaceutiche od affini.

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Site Activation Specialist

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Location: Home-based Italy (preferred big and well-connected cities, usually Milan or Rome)
Work mode: Minimal travel up to 25% may be required
Contract: Permanent

Job summary:
Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for the delivery, with oversight from the Line Manager in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, collection and review of essential documents required for site initiation and site activation activities. Ensures local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards. Ensures an efficient start-up process on assigned studies. May act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs) under the supervision of the Project Lead (PL) or Site Activation Manager (SAM) as appropriate, may directly interact with Customers regarding requirements from RA or other local regulatory party.

Job responsabilities:

General – Responsible for providing quality on deliverables at the country level and follows project requirements and applicable country rules, with oversight from the SSU Country Manager.
Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached provides clear rationale for delays, assists with contingency plan to mitigate impact, and escalates the issue as soon as identified.
Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

Responsible for one or more of the following functions at the country level:

Local Submissions Specialist - Follows the project direction provided by the designated country startup advisor (CSA) and SAM. May serve as a point of contact for the SAM/PM (or designee) during startup on allocated projects. Compiles and/or reviews essential document packages for site activation and may also be involved in essential document collection from site.
Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required and under supervision.
May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversee site activation end to end process at country/ site level.
Local Site ID and Feasibility Support – Provides support with site selection lead and PM/SAM to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
May be asked to perform: Local Investigator Contract and Budget Negotiator – Supports the SAM to agree on country template contract and budget. Assists in producing site-specific contracts from country template. Under supervision assist in negotiations of budget and contract with site and via Site Contracts Service Centre and SAM lead with Sponsor until resolution of issues and contract execution.
Assists with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.

What we’re looking for:

Associate’s Degree or equivalent combination of education and training.
Good understanding of clinical trial process across Phases II-IV and ICH GCP, Ability to interact effectively and appropriately with investigative site personnel.
Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively.
Good English skills.
Strong computer skills, including Word, Excel, PowerPoint, Publisher.

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Regional Planner - Pomezia (RM)

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Location: Pomezia (RM)
Work Mode: on site & smart working
Contract: temporary contract (12 months) with the possibility of personal and professional growth. Level and salary will be defined on the candidate's real skills.

Responsabilities:

Master data maintenance in SAP;
Order management activities;
Generation of reports related to Supply chain performance management. (eg. PA, OTiF; volume tracking);
Check for system synchronization consistency.

Requirements:

Previous experience in Supply Chain Planning and ideally in another related Supply Chain field such as Procurement, Manufacturing or Logistics, Plant planning experience, experience in SAP R/3 and APO are a plus,
Excellent Knowledge MS Office, especially strong Excel capabilities,
Fluent English. It’s also a plus the knowledge of another language (Spanish, Portuguese, German, Greek, French),
Positive mindset and a dynamic
Self-starter personality.

Titolo di Studio: Laurea in Ingegneria, Supply Chain, Logistica o Business Administration

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Stage Marketing area respiratoria – Milano

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Sede: Milano
Modalità: ibrida
Tipologia di contratto: stage curriculare o extracurriculare di 6 mesi, con possibilità di proroga.
È previsto un rimborso spese e buoni pasto.

Sanofi, azienda multinazionale farmaceutica, sta ricercando per la propria sede di Milano una risorsa da inserire in stage all'interno del dipartimento Marketing della Business Unit Specialty Care, area Respiratoria. La risorsa supporterà il Tutor di riferimento in tutte le attività legate al dipartimento, partecipando attivamente e ricevendo formazione on the job.

Le attività di cui si occuperà saranno principalmente:

Supporto nella realizzazione del piano comunicazionale e mezzi promozionali;
Affiancamento e supporto nell’organizzazione di eventi scientifici, meeting interni, riunioni di ciclo e sponsorizzazione a congressi nazionali ed internazionali;
Gestione di progettualità specifiche marketing a supporto del tutor;
Partecipazione a conference call e meeting aziendali;
Elaborazione di file Excel e presentazioni Power Point.

Requisiti:

laurea in discipline scientifiche;
master in marketing o management farmaceutico;
ottima conoscenza del pacchetto Office;
ottima conoscenza della lingua inglese (livello B2).

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Stage Reliability Methods & Maintenance Planning – Scoppito (L’Aquila)

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Sede: Scoppito (L'Aquila)
Modalità: presenza
Tipologia di contratto: stage extracurriculare di 6 mesi, con possibilità di proroga.
È previsto un rimborso spese e accesso gratuito alla mensa aziendale.

Sanofi, azienda multinazionale farmaceutica, ricerca per il proprio stabilimento produttivo di Scoppito (L'Aquila) una persona da inserire in stage nell'area Reliability Methods & Maintenance Planning. La risorsa supporterà il Tutor di riferimento in tutte le attività legate al dipartimento, partecipando attivamente e ricevendo formazione on the job.

La persona selezionata supporterà il programma di aumento di affidabilità degli asset di produzione (Manufacturing e Packaging) del sito produttivo.

Le attività di cui si occuperà saranno principalmente:

Introduzione al modello di Value Driven Maintenance della company;
Introduzione alla gestione dei piani di Manutenzioni Preventiva;
Analisi sul campo delle operazioni di Manutenzione Preventiva;
Revisione procedure e istruzioni di manutenzione;
Analisi e revisione delle spare parts list degli asset di produzione;
Utilizzo del sistema SAP per la gestione delle manutenzioni;
Analisi statistiche di affidabilità;
Gestione documentazione tecnica;
Partecipazione ai team/ progetti di performance relativi alla digitalizzazione/ Industry 4.0;
Coinvolgimento nel progetto di gestione obsolescenze basato sulla analisi dei dati di reliability e costi, manuali e contatti con i fornitori.

Requisiti:

Laurea in ingegneria chimica o altri percorsi di ingegneria
Buona conoscenza della lingua inglese
Familiarità con i tool informatici Office (in particolare si richiede un’ottima conoscenza di EXCEL, gradita conoscenza di PowerBI e di linguaggio PYTHON)
Conoscenza dei principali strumenti di analisi statistica
Team working e capacità di analisi

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EU QA Officer

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Location: Malta Office - APL Swift Services (Malta) Ltd, HF26, Hal Far Industrial Estate, Birzebbugia BBG 3000 Malta

Objectives:

Assists the European Quality Manager in the day-to-day operation and management of the quality system according to EU GxP requirements
Assists the European Quality Manager in the upkeep of the Regulatory Compliance.
Maintenance and management of all GxP documentation pertaining to CMOs.

Tasks and Responsibilities:
Support manager in the management of all CMO relations including:

Quality Management Systems such as Complaints, Deviations, PQR, Change Controls, TA’s and CAPA’s.
Follow up on Supplier audits and qualification system.
Support EU Quality team in relation to EMA requirements.
Overseeing Quality tracker Metrics of the European Aurobindo Affiliates.
Supporting with performing audit of the European Aurobindo Affiliates.
Carry out other duties as required.

The ideal candidate must:

Have a minimum of 2-year experience within Pharmaceutical Company - QA department QMS

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Medici di Reparto (con o senza specializzazione) - varie sedi

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Requisiti:
• Laurea in Medicina e Chirurgia e Iscrizione all’Ordine dei Medici
La ricerca è rivolta a entrambi i sessi (Legge 903/77 e art.8 D.lgs 196/00)

Tipologia contrattuale:
• Stipula di contratto libero professionale con P.IVA o assunzione a tempo indeterminato
• Impegno orario settimanale da concordare con la struttura
• Compenso in linea con i valori della Sanità Pubblica
• Piattaforma scontistica riservata ai dipendenti/collaboratori KOS
• Percorsi di formazione aziendale attraverso la nostra Kos Academy

Sedi di lavoro:

LOMBARDIA
• Residenze Anni Azzurri site in provincia di Milano, Bergamo, Brescia e Monza

LIGURIA
• Residenze Anni Azzurri site in provincia di Genova e Imperia

VENETO
• Residenza Anni Azzurri a Favaro Veneto- Mestre (VE)
• Residenza Anni Azzurri a Quarto D’Altino (VE)

EMILIA ROMAGNA
• Residenza Anni Azzurri Idice a Castenaso (BO)

MARCHE
• Clinica Specialistica Psichiatrica Villa Jolanda a Maiolati Spontini (AN)
• Santo Stefano Riabilitazione Residenza Dorica ad Ancona
• Santo Stefano Riabilitazione a Macerata Feltria (PU)
• Santo Stefano Riabilitazione Villa Fastiggi a Pesaro
• Santo Stefano Riabilitazione a Porto Potenza Picena (MC)

UMBRIA
• Santo Stefano Riabilitazione a Foligno (PG)

CAMPANIA
• Santo Stefano Riabilitazione Villa Margherita a Benevento

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Qualification Specialist

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Location: Latina Scalo (LT) - Lazio
Contract: 6 months of paid Internship

Main Activities:

Analysis of technical documentation

Ensure the analysis and evaluation of technical documentation related to equipments and utilities to be qualified, in order to acquire information necessary for the definition of protocols and the execution of qualification activities in compliance with company procedures;

Definition of qualification documents

Ensure the drafting of qualification documents (Risk Assessment, DQ-IQ-OQ-PQ Protocols, Validation Master Plan, Validation Plan, Project Qualification Plan), by researching and acquiring from other corporate functions the data and information necessary to define their contents and to settle the qualification strategy;

Qualification

Ensure within the required tiem frame the proper qualification of equipments and utilities, through the execution of the operational activities provided for in the Protocols (DQ-IQ-OQ-PQ Protocols). In collaboration with the Purchasing function, formulate bid requests to suppliers and support the Manager, preparing a technical and economic analysis of the bids received;

Qualification Reports

Ensure the proper preparation of Qualification Reports (DQ-IQ-OQ-PQ Reports), based on the analysis of data generated from validation activities, in compliance with company protocols and procedures;

Main Requirements:

Master's Degree in Chemical Engineering/CTF/Chemistry/ Biomedical Engineering
Knowledge of GMP
English
Can-do attitude

At BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. We respect the diversity , the different backgrounds and experiences and provide equal opportunity for all. We are BSP!

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Scientist

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Employer: Lundbeck
Location: Copenhagen, Denmark

Job description:
Are you a highly motivated Scientist with a genuine interest in Translational Biology, experience with immunoassays and bioanalysis and a solid understanding of biomarker applications. Then you may be a great addition to our team of scientists in the discovery of transformative treatments for neurological disorders.

As a Scientist, you will contribute to our biomarker discovery efforts in in vivo pharmacology and pharmacodynamics studies.

Your key tasks and responsibilities:

Conduct hands-on laboratory work in support of drug discovery programs;
Perform quantitative bioanalysis using fit-for-purpose assays (e.g., commercial ELISAs, MSD, GyroLab) for quantification and qualification of new biomarkers in preclinical and clinical samples in collaboration with technicians and other colleagues across Lundbeck R&D;
Adopt and develop new fluid biomarker modalities such as Flow Cytometry based analysis (i.e., whole blood/PBMC, FACS, microRNAs microvesicles (MVs) and exosomes);
Actively seek external inspiration for optimisation of our methodologies and stay up to date with scientific advancements to ensure our continuous development;
Direct studies through external partners such as CROs and approved vendors;
Contribute to development of translational strategies for Target engagement, Mechanism of action, and Pharmacodynamic biomarker exploration;
Engage in multidisciplinary project teams and contribute to cross functional biomarker teams whilst working collaboratively with colleagues across Lundbeck R&D;
Promote a culture of diversity, innovation, and curiosity, while maintaining accountability and timely delivery of high-quality decision-enabling data.

Requirements:

You hold a PhD degree in Biomarker assay development, Life Sciences, Neuroscience or a related discipline relevant to pharma/biotech research and development, with 1-3 years post-PhD experience
You have experience and good understanding of translational research in both preclinical research and early clinical development settings.

In addition, you bring:

Experience with translational biomarker development (pharmacodynamic, predictive and fit-for-purpose qualification) including experience with quantitative bioanalytical assays, developing assays, qualifying assays, automation, and process optimization
- Experience of (soluble) biomarker assay platforms (e.g., ELISA, MSD-ECL, Simoa, O-Link and GyroLab) is highly desirable
- Experience with biomarker innovation; specifically with Flow Cytometry based analysis (i.e., whole blood/PBMC, FACS, microRNAs, microvesicles (MVs) and exosomes), or neuroinflammation related immunoassays is highly desirable

FELASA B or equivalent, and experience in in-vivo study planning (good organizational mind-set) and execution is ideal
Good statistical analysis skills
Experience working within cross-functional project teams, and a proven history of successful collaboration with internal or external teams at contract research organizations and academic laboratories
Proficient in oral and written English, and good effective communication skills with demonstrated ability to deliver presentations in a broad range of settings.

Your future team:
The Department of Preclinical Fluid Biomarkers and Occupancy is based at Lundbeck’s R&D headquarter in Valby, Copenhagen. The department comprises a small team of 8 members, including scientists, laboratory technicians and students, and our team is currently expanding.

Our department supports research projects with generating comprehensive in vivo pharmacology data packages for new drug candidates in Lundbeck’s R&D pipeline. We do this by testing the pharmacological effect of compounds in mechanistic animal models and by measuring related fluid biomarker changes. Bioanalyses are run on multiple immunoassay platforms, including as e.g., ELISA, Gyros and MSD

---

About Lundbeck

Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research.

We are tirelessly dedicated to restoring brain health, so every person can be their best. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options.

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QA-RA Compliance Officer

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Location: Malta Office - APL Swift Services (Malta) Ltd, HF26, Hal Far Industrial Estate, Birzebbugia BBG 3000 Malta

Objectives:

Assists the Quality Assurance Manager in the day-to-day operation and management of the quality system according to EU GMP and GDP.
Assists the Quality Assurance Manager in the upkeep of the Regulatory Compliance and local regulatory activities.
Maintenance and management of all GMP and GDP documentation generated by the company.

Tasks and Responsibilities:
You will work in the Quality Unit and you will report to the QA Manager:

Distribution and control of quality documentation.
Updates QA documentation, maintain quality logs and document registers.
Participates in the self-inspection program to audit operational practices and staff for compliance with established documentation, policies and procedures.
Compilation/ review of periodical Product Quality Reviews.
Receipt, reporting of customer complaints and follow-up investigations with the manufacturer and the customer.
Analytical test methods and specifications regulatory compliance review.
Review and distribution of the Product Approval Package (PAP).
Review and approval of Printed Packaging Materials Artwork.
Review and maintenance of (Item) Master Data in Oracle.
Maintenance of Supplier audits and qualification system.
Verification and maintenance of suppliers/ customers certifications and licensing status.
Review and maintenance of Business Partners Master Data in Oracle.
Upkeep and maintenance of Quality Technical Agreements and Service Agreements.
Oversees the manufacturers’ change control program in relation to regulatory updates.
Review CAPAs to ensure all actions are implemented and adhered to for quality compliance. Oversees the CAPA Program to monitor the effectiveness of CAPA, as a means of continuous improvement.
Reviews and process internal change requests. Participates in Change Control assessments, as required, and project meetings to ensure the compliant status of affected equipment/ systems/processes is not compromised.
To liaise effectively with other departments to ensure assigned validation exercises are conducted in a timely manner and in compliance with GMP.
Ensures all new and existing equipment is assessed appropriately and validated for its intended use. Coordinates procedure/ process testing and provides reviews of audit trails.
Ensures all software used for the generation of Good Manufacturing Practices (GMP) activities meets the standards required for data integrity compliance.
Review of protocols and reports from other departments/ companies.
Assists the Quality Assurance Manager during regulatory and customer audits.
Carry out other duties as may reasonably be required.

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Junior Quality Control Analyst

QA Specialist, Corporate Product Quality Biologics

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Employer: Lundbeck
Location: Copenhagen, Denmark

Job description:
Are you looking for a new opportunity within Quality Assurance and working with biopharmaceuticals in a dynamic environment then this is the job for you.

As we are expanding our Corporate Product Quality Biologics (CPQB) team we are now looking for a QA Specialist working with biopharmaceuticals in an exciting role with many points of contacts, complex problem solving and a variety in your daily work tasks.

In this job, you will have an important role in CPQB in collaboration with the designated QP of commercial biologics and your skilled colleagues in CPQB.

Your key tasks and responsibilities:

Many varied tasks related to several aspects of the Quality Assurance for both Bulk Drug Substance (BDS), Drug Product (DP) and Finished Product (FP);
This includes reviewing/approving documentation related to manufacturing and analysis e.g. batch documentation, deviations, master batch records, change requests, contact to vendors and QP-release;
The role will also include improvement projects, collaborations internally, harmonization of processes and an opportunity to influence and continuously improve the quality systems.

Requirements:
You are professional, self-driven and experienced with the following skills and competencies:

Relevant education, such as Master's degree in Pharmacy with +5 years of relevant experience
Meets the requirements to act as QP-delegate and experience in QP-release
An effective communicator on all levels of an organization with a personal drive
Solid understanding of biologics production
Experience with analytical methods
Experience working with tasks like deviations, change requests, release, complaints and PQR
The ability to proactively handle multiple tasks simultaneously together with a positive attitude towards work assignments, colleagues and stakeholders

Your future team:
The position is based in Valby HQ where you will report to the Director of QA biologics. Some international travel is required.

The daily interactions will be with the QA biologics team and peers in Quality Control, Biologics production, Development, Regulatory Affairs and Supply Chain which together form a coherent and inspiring community.

---

About Lundbeck

Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research.

We are tirelessly dedicated to restoring brain health, so every person can be their best. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options.

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Junior MS&T Officer

Psicologo - Piemonte

Global CSV Associate

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Context:
The candidate will be a new resource of the Global CSV team inside the Global Menarini Quality Assurance department and will be placed in a work team composed by young people.
The candidate will have to work in collaboration with the CSV and QA representatives of Menarini affiliates (Italian and foreign).
In the first period the candidate will support other team members on the ongoing projects, but the aim is to find a person able to quickly operate independently.

Main activities and responsabilities:

Management of Validation projects among several sites of the Menarini group.
Design of new system requirements and processes.
Issue of validation documents.
Issue of SOP dedicated to Computerized system management and validation.
Supervising the execution of tests in collaboration with business key use.
Technical skill required: good knowledge of Office package, Project, Google platform.
Ability to manage and coordinate competences provided by other professional workers.
Main internal stakeholders: QA, IT, BST, Engineering, C&Q.
Main external stakeholders: validation consultant, sw supplier/system integrator.

Job requirements:
Education

Degree in Engineering, Chemistry, CTF

Qualification and skills

The candidate should be independent at work and should have a good ability to relate to higher functions (also related to other Menarini sites)
The candidate should have good team working skills, striking up interpersonal relationships
The candidate should have ability to work under stressful condition and meet deadlines

Language skills

Excellent knowledge of written and spoken English.

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Stage Quality Assurance System – Anagni (Frosinone)

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Sede: Anagni (Frosinone)
Modalità: presenza
Tipologia di contratto: Si offre uno stage curriculare o extracurriculare di 6 mesi, con possibilità di proroga.
E' previsto un rimborso spese e accesso gratuito alla mensa aziendale.

Sanofi, azienda multinazionale farmaceutica, ricerca per il proprio stabilimento produttivo di Anagni (Frosinone) una persona da inserire in stage nel dipartimento Quality Assurance. La risorsa affiancherà il responsabile della funzione Quality Assurance System nella gestione, organizzazione e mantenimento del Sistema Quality locale, assicurando il pieno e continuo rispetto dei requisiti GMP delle Autorità Regolatorie Nazionali ed Internazionali e degli Standard Corporate.

Le attività di cui si occuperà saranno principalmente:

Supporto nella gestione di SOP/Metodi di analisi di sito e cura della migrazione da sistema cartaceo a informatico;
Controllo della corretta attuazione dell'iter di revisione e approvazione delle SOP e dei Metodi di Analisi;
Monitoraggio delle scadenze e revisioni delle SOP e dei Metodi di Analisi e altra Documentazione di Qualità;
Gestione anagrafica e rilascio codici materiali in SAP con supporto VISTA;
Supporto alla redazione delle Annual Product Review dei prodotti Sanofi.

Requisiti:

Laurea scientifica
Buona conoscenza della lingua Inglese (livello minimo B2)
Pacchetto Office
Precisione, motivazione e abilità di team working
Automunito/a.

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Farmacista - Nord e Centro Italia

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Sedi: Punti vendita distribuiti nel Nord e Centro-Italia*
Modalità: in Sede – farmacia e/o parafarmacia
Tipologia di contratto: Tempo determinato o indeterminato in base all’esperienze

Descrizione delle mansioni:

consiglio e vendita alla clientela;
vendita di farmaci, parafarmaci e prodotti dermocosmetici;
erogazione di servizi quali: misurazione pressione, glicemia, colesterolo, peso, vitamina D;
analisi capello, pelle, cellulite;
analisi intolleranze alimentari;
test disbiosi;
sistemazione merce e attività di back office.

Lauree: Farmacia e/o Chimica e tecnologie farmaceutiche

*Città punti vendita
Importante: specificare nella cover letter per quale/i città ci si candida

Milano,
Monza-Brianza,
Cremona,
Varese,
Bergamo,
Brescia,
Lecco,
Tortona-Serravalle,
Cornate d’Adda,
Verona,
Vicenza,
Padova,
Parma,
Bologna,
Modena,
Sassuolo,
Ferrara,
Forlì-Cesena,
Prato,
Firenze,
San Giovanni Valdarno,
Roma

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Technical Office Support

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Sede: Sesto Fiorentino (FI)
Modalità: ibrida
Tipologia di contratto: apprendistato/tempo indeterminato

Descrizione mansioni:

proporre soluzioni e migliorie al sistema di gestione documentale con l’obiettivo di razionalizzare i flussi di processo;
gestire i progetti per arrivare al conseguimento previsto dei milestone;
gestire e programmare modifiche e aggiornamenti di layout;
la pianificazione delle attività, mediante diagrammi GANTT, sul corretto svolgimento delle attività di cantiere;
eseguire attività di analisi dei dati e stesura della reportistica dei KPI;
analisi dei processi per garantire la correttezza e la completezza dei documenti per il futuro archivio;
analisi della compliance dei documenti gestiti ed archiviati presso l’ufficio tecnico;
attività di gap analysis actual vs requested;
attività di archiviazione dei documenti relativi all’engineering library, documentazione tecnico urbanistica e libretti di manutenzione.

Lauree: discipline ingegneristiche, preferibilmente in ingegneria gestionale

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Inventory Controller Specialist - Pomezia (RM)

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Sede: Pomezia (RM)
Moadalità: on site & smart working
Tipologia di Contratto: somministrazione a tempo determinato di 12 mesi con possibilità di crescita personale e professionale. Livello e retribuzione da definire sulla base delle reali competenze del candidato.

Mansioni:

Predisporre la documentazione e attivare le procedure operative propedeutiche all'inventario fisico del magazzino e del Conto deposito;
Analizzare le differenze riscontrate e condividere la relativa reportistica;
Comunicare e coordinarsi con Il Business Management, i Financial Controllers e il Direttore finance al fine di raccogliere le autorizzazioni necessarie alla contabilizzazione delle differenze inventariali;
Supportare le attività di Audit;
Guidare il business sulle opportunità di redeployment degli assets aziendali utilizzando gli strumenti analitici aziendali.

Completa il profilo:

fluente conoscenza della lingua inglese,
attenzione ai dettagli,
buone capacità analitiche,
familiarità con modelli statistici e abilità nella restituzione dei dati al business,
L'esperienza pregressa nella gestione e organizzazione di Data Sets ampi, in Data Acquisition e nell'utilizzo di Transformation and Visualisation tools. (e.g. Python, R, SQL, Tableau, PowerBI etc) sarà considerata preferenziale.

Titolo di Studio: Laurea specialistica in Ingegneria, Economia, Supply Chain, Statistica.

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Coordinatori Infermieristici - Piemonte

Scientist for Manufacturing Product Support

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Employer: AGC Biologics
Location: Copenhagen, Denmark

Do you have experience working in a cGMP environment and are you looking for new opportunities for further growth? Then this position could be something for you.

Job description:

Right now, you have the opportunity to join the Manufacturing Product Support department as an upstream Scientist in one of the Commercial teams. This position requires technical problem-solving, process understanding and inter-departmental collaboration.

The Commercial team owns the production process of all commercial products. This includes to support the value streams with an error-free and timely production execution and own batch documentation, review and deviation handling. The team has in depth knowledge of the commercial product specific requirements.

Tasks and Responsibilities:

Prior to batch execution

Accountable for MPR creation, high level batch initiation process and cleaning procedure for product contact items
Responsible for reviewing MPI and BOM
Responsible for MPR (project specific) training of technicians

Batch execution

On call/shopfloor scientist to ensure on the line support during critical process steps
Responsible for facilitating solutions on how to proceed during break-down during batch execution
Responsible for participating during ENG batch

After batch execution

Accountable for timely deviation closure (incl. systematic problem-solving during root cause investigation)

Other:

Customer meeting representative
Audits and inspection support
Responsible for capturing learnings and implement cont. improvements to process
Knowledge about requirement for commercial products.

Your profile:
The ideal candidate holds an Academic degree within science and have previously been working in a manufacturing team operating under cGMP preferably within the pharmaceutical industry. The ideal candidate for the position has several of the below competencies/experiences:

Master’s Degree in Engineering or Protein Science-related field
Experience in upstream operations, preferably in clinical/commercial GMP manufacturing.
Have experience with and demonstrated understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g., ICH Q7A, 21 CFR Part 211, etc.).
Have experience writing, reviewing and approving GMP documentation.
Experienced with operations of single-use technologies and aseptic processing.
Self-motivated, organized and proactive.
Ability to coordinate multi-departmental tasks and deliverables (interaction with Process Transfer, Process Development, Engineering, QA, QC, etc.).
Experience working with multiple projects simultaneously.
Demonstrated experience leading troubleshooting efforts.
Strong communication skills necessary to interact with internal and external stakeholders.
Strong presentation skills.

---

About the Company
AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services. Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.

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Stage Chimico e Microbiologico - varie sedi

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Sedi: HUB di Oderzo, Torino, Firenze, Battipaglia, Firenze e Padova

Attività previste dello stage:

Introduzione al laboratorio: visione del flusso di lavoro:dall'accettazione del campione al rapporto di prova, significato del lavorare secondo 17025.
Introduzione graduale ai metodi e allo svolgimento delle prove (estrazione/preparativa), lettura del metodo normato e della PD interna relativa.
Introduzione al prolab per vedere i controlli associati ai campioni accettati.
Metodologie di lavoro specifiche, uso corretto degli strumenti di base
Come lavorare in sicurezza

Background:

Diploma scienfifico e/o Laurea in Chimica, Biologia, CTF.
Se avuto esperienza di alternanza scuola lavoro o stage curricolari in laboratorio di matrice ambientale/alimentare un plus.

Segnare nell'oggetto della cover letter la sede per cui ci si candida!

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Experienced QA Associate for Drug Substance

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Employer: Fujifilm Diosynth Biotechnologies
Location: Hillerød (Denmark)
Contract: Full-time

Are you a skilled and experienced Quality Assurance specialist eager to join a fast-growing CDMO? Do you want to be an important part of developing and ensuring our quality aspirations?
Then Apply for this Position and Follow Your Genki to FUJIFILM Diosynth Biotechnologies

Job description:
You will take on a role as a QA partner for all activities related to Drug Substance Manufacturing activities, daily operations, optimization projects, expansion programs, and partner collaborations.

You will be part of the DS QA department. Currently the department consists of 30 dedicated QA’s that covers the Drug Substance Manufacturing operation and project activities, along with project related expansion activities. We are a dynamic department in daily contact and in close collaboration with all internal stakeholders and QA colleagues.

Daily, the department is structured in three teams, Upstream-, Downstream- and a QP-team. Currently, we are hiring for the Upstream and Downstream teams.

Task:

Review and approval of documentation related to our equipment (maintenance, modifications, validation, and alarms-handling etc.)
QA review and approval of documentation related to our automation systems
Performing batch review, ensuring the batch has been manufactured and tested in accordance with GMP regulations and quality agreements.
Approval of campaign change over from one product to another
Taking on the QA role in technical transfer operations and approval of related change controls and documents.
To help maintain the quality system on the current GMP, Good Documentation Practice, regulatory requirements and quality oversight.
Approval of procedures, deviations, change controls, CAPAs etc.

Qualifications:
Professional qualifications

University degree in pharmacy, medicine, veterinary science, pharmaceutical chemistry and technology, chemistry, biology or similar
Knowledge of GMP quality systems and legislation.
Understanding of the complexity of manufacturing biologics

Personal qualifications

Thrive in a changing environment
A team player
Enjoy working with multiple stakeholders in a large organization
Proactive in your approach
Able to work independently

---

About the company:
FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

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Stage Clinical Project Leader Support – Milano

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Sede: Milano
Modalità: ibrida
Tipologia di contratto: stage curriculare o extracurriculare di 6 mesi, con possibilità di proroga.
È previsto un rimborso spese e buoni pasto.

Sanofi, azienda multinazionale farmaceutica, ricerca per la propria sede di Milano una risorsa da inserire in stage, all'interno del dipartimento Clinical Study Unit (CSU). La risorsa supporterà il Tutor di riferimento in tutte le attività legate al dipartimento, partecipando attivamente e ricevendo formazione on the job.

Le attività di cui si occuperà saranno principalmente:
Affiancamento a un leader di progetto di ricerca clinica per seguire le attività di coordinamento e gestione di una sperimentazione clinica, quali:

Sottomissione ai comitati etici e alle autorità regolatorie;
Supporto nella tracciatura e gestione delle problematiche riscontrate dal team di monitoraggio durante le visite presso i centri;
La pianificazione delle attività del progetto (dalla selezione dei centri, alla gestione del farmaco, alla revisione delle procedure per ottemperare ai requisiti sulla sicurezza del farmaco, all’archiviazione corretta dei documenti necessari di studio) al fine di raggiungere gli obiettivi previsti;
Supporto alla supervisione e aggiornamento del budget allocato allo studio clinico;
Elaborazione di file Excel e presentazioni PowerPoint.

Requisiti:

Laurea in disciplina scientifica (farmacia, biologia, CTF);
Buona conoscenza dei principali strumenti informatici di lavoro (in particolare Power Point e Excel);
Ottima conoscenza della lingua Inglese.

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Regulatory Affairs Senior Consultant – Italy

Tecnico di Laboratorio Microbiologico - Latina

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Sede: Latina
Modalità: on site, con disponibilità al lavoro su 2 turni di lavoro o a ciclo continuo
Tipologia di Contratto: orma contrattuale e livello retributivo commisurati alla reale esperienza del candidato

Mansioni:

Effettuare le analisi microbiologiche, delle acque e dei vapori;
Condurre i test di sterilità sui campioni dei prodotti;
Eseguire l’analisi del Bioburden sui prodotti al fine di valutare i livelli di contaminazione in conformità ai protocolli ed agli standard di qualità aziendali.

Completano il profilo:

L’esperienza di almeno 6 mesi in ruolo analogo;
L’abilità nell'uso della strumentazione di laboratorio;
L’attitudine alla precisione ed all'accuratezza dei risultati;
La capacità di lavorare in team;
Saper comunicare efficacemente.

Titolo di Studio: Laurea in discipline scientifiche quali Biologia o Biotecnologie.

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Operatore di Miscelazione - Crema (CR)

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Sede: Ceram (CR)
Moadalità: on site
Tipologia di Contratto: la forma contrattuale ed il livello di inquadramento saranno commisurati alla reale esperienza del candidato.

Mansioni:

Pesatura delle materie prime;
Caricamento e sorveglianza dell’impianto (turboemulsori) rispettando la scheda di lavorazione ed eseguendo la ricetta secondo la sequenza e la quantità indicata;
Aggiornamento della scheda e del versato di produzione;
Movimentazione delle materie prime attraverso l’uso del transpallet.

Completa il profilo:

la conoscenza dei criteri di qualità di produzione farmaceutica,
la pregressa esperienza di almeno biennale in settore produttivo analogo,
la precisione,
proattività e autonomia nello svolgimento delle mansioni assegnate,
disponibilità a lavorare a giornata e su turni.

Titolo di Studio: Diploma di Perito Chimico o affini

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Life Sciences - Pharma & Biotechnology - Talent Pipeline for Student Assistant positions

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Employer: Novo Nordisk
Location: Bagsværd, Denmark
Role: General Management and Administration
Working hours: between 8 – 20 hours per week

From molecule to market, our focus is always on the patient when developing best-in-class treatments. Long-term thinking drives all our activities, and we continuously demonstrate our commitment to environmental and social responsibility. This sets us apart from other pharmaceutical companies. And now you can start your life-changing career and be a part of this journey. Are you looking for an opportunity where you can explore how to use your theoretical knowledge in everyday business life? Then apply and join our Life Sciences – Pharma & Biotechnology Talent Pipeline.

You will support a lot of colleagues with different backgrounds such as:

Analytical or formulation scientists and technical
Bioinformaticians
Cardiovascular researchers
Medical doctors
Modeling and data scientists
Oral formulation researchers

The Life Science – Pharma and Biotechnology Talent Pipeline covers Student Assistant positions in the following fields:

Research and development
Medicine
Clinical Science
Quality control
Stem cell biology
Regulatory Affairs

Qualifications:

Bachelor’s or Master’s degree in Life Sciences, e.g. Cell Biology, Human Biology, Biochemistry, Bioengineering, Medicine, Pharmacy, or another relevant field
you have at least 12 months left of your studies
you are keen to learn and able to manage your own time
It’s an advance if you have laboratory experience and are used to working with a various number of stakeholders
Fluent in English > you need to submit your CV in English.

Student Assistant position details:
A Student Assistant position in Novo Nordisk is between 8 – 20 hours per week, but most Student Assistant positions are 10 – 15 hours per week with a small possibility to work from home – most of the work will be on-site. For Novo Nordisk, you as a student must get the flexibility that allows you to prioritise your exams and assignments as needed.

A Danish work permit is required.

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Joining a Talent Pipeline in Novo Nordisk
Most of our Student Assistant positions a filled through our Talent Pipelines which means that by joining the pipelines you will get the opportunity to get matched with a lot of positions that never get posted.

When applying to this Talent Pipeline you will be considered as a potential match for several Student Assistant positions within the fields of Finance, Procurement, Strategy, and Law, and if there is a match, we will reach out to you and invite you for a 1st interview with the hiring manager.

You will only be contacted if we find a relevant position that matches your profile, but you will remain part of the Pipeline for up to 6 months unless you inform us that you wish to withdraw.

Due to GDPR regulations, we are closing the pipelines after 6 months and we send email notifications to all active candidates in our pipelines when they are closed, - with a link to where you can re-apply to our new line of Talent Pipelines.

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Project Engineer - API Plant

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Location:

As a part of the technical services department of the Plant (Active Pharmaceutical Ingredient manufacturing process) we are hiring a Project Engineer.

Your key tasks and responsibilities:

Supervise new project assigned by Head of Engineering of the plant;
Planning, coordinating and executing the design;
Define requirements and coordinate requests for new projects and production equipment updates;
Provide the technical skills necessary for the resolution of problems related to the plant;
Collect, analyze and report equipment downtime information to improve plant maintenance and performance;
Ensure the resolution of critical equipment issues.

Requirements:

Master’s Degree in Chemical, Electrical, Electronic, Mechanical Engineering or in related disciplines, with a minimum experience in the role;
Knowledge of regulatory requirements and GMP for pharmaceutical production;
Knowledge and experience in chemical-pharmaceutical production processes, as well as in the development and implementation of new processes;
Experience in process validation and plant qualification (IQ/OQ/PQ), managing new equipment and solving their technical problems.

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Quality & Operations Consultant

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Sede: Latina (LT) - Lazio
Spostamenti: Disponibilità a viaggiare su tutto il Territorio Nazionale secondo le necessità di progetto per il raggiungimento degli stabilimenti dei clienti.
Tipologia di contratto: Tempo indeterminato – Full Time
L’inquadramento e il pacchetto retributivo saranno commisurati all’esperienza del candidato.

Responsabilità:

Stesura di documenti di qualifica/riqualifica prevista per la gestione del life cycle del sistema;
Redazione ed esecuzione dei documenti di qualifica del sistema (IQ/OQ/PQ) con strumentazione critica di qualifica;
Attività di Quality Assurance e Compliance in aderenza alle normative e linee guida di riferimento;
Attività di Risk Management;
Consolidamento nel tempo dei rapporti con i clienti riportando al Team Supervisor eventuali nuove esigenze;
Aggiornamento periodico al Team Supervisor ai fini dell’allineamento/scostamento con le previsioni fatte in merito all’avanzamento dei progetti.

Requisiti:

Laurea triennale o magistrale in materie tecnico-ingegneristiche (Ingegneria Chimica, Chimica, Chimica Industriale, Ingegneria Meccanica, CTF, Farmacia);
Almeno 2 anni di esperienza sul campo in ambito Life Science;
Buona conoscenza delle Normative e linee guida cGMP;
Buona conoscenza della lingua Inglese sia scritta che parlata;
Ottima conoscenza del pacchetto Office.

Si offre: sistema di welfare, previdenza complementare aziendale, benefit, formazione continua, eventi.

Presenta il tuo cv alla nostra mail selezione@s4btsrl.com

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Informatore Scientifico del Farmaco - varie sedi Italia

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Sedi: Milano Sud; Cremona; Civitavecchia; L’aquila/Teramo; Pesaro/Urbino; Ancona; Udine; Lecco/Sondrio
Modalità: in presenza sul territorio
Tipologia di contratto: contratto tempo determinato in somministrazione di 1 anno (opportunità di inserimento).

Descrizione mansioni:
Il Gruppo Servier Italia ricerca una figura di Informatore Scientifico del Farmaco che, riportando all'Area Manager, dovrà assicurare regolari contatti e visite verso i medici di Medicina Generale e Medici Specialisti dell'Area assegnata.

Requisiti:

Esperienza: almeno 6 mesi nel ruolo
Costituisce requisito preferenziale la conoscenza del territorio
Buona conoscenza della lingua inglese
Ricerchiamo candidati con forte entusiasmo, curiosità, intraprendenza, empatia, capacità relazionale. Desiderio di crescere nel ruolo di ISF.

Lauree: Laurea in Discipline Scientifiche (Scienze Biologiche; Chimica (indirizzo organico o biologico); Farmacia; CTF; Scienze Naturali; Diploma di laurea in Informazione Scientifica del Farmaco ecc.)

Nella cover letter specificare per quale sede ci si sta candidando.

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Quality Assurance Specialist - Monza

Medical Affair Manager

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Alla luce delle profonde trasformazioni che stanno attraversando il mondo farmaceutico e più in generale il mondo sanitario, il Medical Affair Manager, riportando al Medical Affair Director, si occuperà delle seguenti attività:

Realizzazione dei mezzi per l’informazione medico-scientifica (in linea con la normativa vigente sull’informazione scientifica: legge 219/2006 e Codice deontologico Farmindustria);
Supporto dal punto di vista medico-scientifico la rete degli Informatori Scientifici e dei Capi Area;
Partecipazione ai principali congressi nazionali e internazionali inerenti le aree scientifiche di riferimento;
Valutazione e preparazione di report scientifici in ottica di Business Development;
Supporto medico-scientifico ai processi del regolatorio e della farmacovigilanza per l’area di competenza;
Generazione di relazioni con i principali stakeholders.

Requisito: Verranno prese in considerazione unicamente le candidature con una Laurea in Medicina.

La ricerca è rivolta ad ambo i sessi.

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QA Technician, Corporate Product Quality Biologics

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Employer: Lundbeck
Location: Valby, Denmark

Job description:
Are you looking for a new opportunity within Quality Assurance and working with biopharmaceuticals in a dynamic environment then this is the job for you.

As we are expanding our Corporate Product Quality Biologics (CPQB) team we are now looking for a QA Technician working with biopharmaceuticals in an exciting role.

Your key tasks and responsibilities:Requirements:

Batch review;
Intake of deviations and changes from CMO´s (Contract Manufacturing Organizations);
Archiving of documentation;
Handling of data in LIMS;
SOP´s and various ad hoc tasks to support the daily tasks and projects.

Requirements:

Relevant education like pharmacy technician with several years of relevant experience in the pharmaceutical industry
Experience with biopharmaceuticals
Good English written and oral communication skills
Experience with handling documentation from CMO´s
Familiar with SAP and LIMS

Your future team:
The position is based in Valby HQ where you will report to the Director of QA biologics. The Valby office is the primary workplace.

The daily interactions will be with the QA biologics team and peers in Quality Control, Biologics production, Regulatory Affairs and Supply Chain which together form a coherent and inspiring community.

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About Lundbeck

Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research.

We are tirelessly dedicated to restoring brain health, so every person can be their best. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options.

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Senior Clinical Supply Manager

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Employer: Leo Pharma
Location: Ballerup (Denmark)
Contract: Permanent

Do you want to make a difference in the growing market ensuring our Investigational Medicinal Products arrive at site in due time and at the highest quality standard?

Job description:
If your area of expertise is clinical supply management within clinical trial development, and you are looking for a job with high level impact and freedom to operate, this job is right here. LEO Pharma has set the ambitious goal to become the world’s preferred dermatology care partner. A cornerstone in making this vision come true is our collaboration with many stakeholders such as CROs and CMOs on execution of our clinical trials.

In this position you will get the opportunity to influence the direction for the area. You will do it together with skilled and dedicated colleagues in a very well-functioning team with office in Denmark.

Task:
As Senior Clinical Supply Manager at LEO Pharma, you will be working with a diversity of tasks:

from planning and coordinating clinical supply activities for all development phases
outsourced trials to creating close dialogue and smooth collaboration with our stakeholders and our external vendors.

As you will follow the whole process from start up to finalization, it will be ideal if you have experience in:

Review of overall clinical trial protocol/protocol amendments and preparing other related documents (e.g., trial product handling manual), providing input to develop efficient packaging design, clinical trial supply design and visit schedule
Building and maintaining complete and accurate clinical supply demand for assigned study in alignment with protocol requirements, key study parameters and achievements, patient projections, with appropriate overage and by using defined processes and systems
Developing, maintaining, carrying out an optimal resupply strategy with proactive planning, appropriate lead-time and replenishment quantities to ensure compliance and continuity of clinical supplies, including proactive expire management of clinical supplies
Interactive Response Technology (IRT) Systems
Consolidating, maintaining, and supervising clinical trial budgets with key stakeholders
Ensuring effective collaboration across different organizational levels, functions, and geographies (i.e., Clinical Operations Leads, Quality, CMC, Global Product Supply, Packaging and Distribution vendors etc.) to realize goals and objectives

Qualifications:
To master this position, you:

Hold a degree in a relevant field (e.g., engineering, chemistry, pharmacy)
Have 5-8 years of experience within the pharmaceutical industry, clinical development experience including clinical trial supplies, good understanding of IRT systems and an overall knowledge of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Clinical Practice (GCP)
Proficient in English and Danish at a professional level, both written and spoken, and you master Microsoft Office

As part of a fast-paced organization you must also thrive in an environment of change and be able to navigate in a constructive way without having manuals and procedures for each process.

Your new team:
Your will join a team of 7 positive, experienced, and very dedicated Clinical Supply Managers that all share your professional interest within Clinical Supply.
Our environment is rather fast paced and dynamic, yet it is very important to us to have a good work life balance as we strongly believe that people in good mental balance makes the best results. We think as team, we handle challenges as a team, we win as a team, and we celebrate as a team.

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About the company:
At LEO Pharma, we help people with skin diseases live fulfilling lives by advancing dermatology beyond the skin. We drive dermatology with our knowledge, collaboration, and curiosity, and we are at the forefront of science in developing new medicines. For us, pioneering together is about constantly improving and extending what’s possible for each other, our company, and our patients.

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Clinical Operations Specialist

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Location: Home-based Italy (preferred big and well-connected cities, usually Milan or Rome)
Work mode: Minimal travel up to 25% may be required
Contract: Permanent

Job summary:
The position is responsible for providing clerical, administrative, and technical administrative support to one or more business units or clients within Clinical Operations.

Job responsabilities:

Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions.
Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines.
Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits.
Prepares and maintains site manuals, reference tools and other documents.
Maintains, updates, and inputs clinical tracking information into databases.
Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client.
Manages shared mailbox, processes site requests and routes correspondence appropriately.
Coordinates the ordering, packaging, shipping and tracking of site supplies and materials.
Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items.
May handle receipt, tracking and disposition of Case Report Forms and Queries.
Maintains overall awareness in the field of clinical research by completing all necessary and assigned training.

What we’re looking for:

High School diploma or equivalent
Good communication and interpersonal skills
Ability to embrace new technologies

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Medici Specialisti - varie sedi Italia

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Requisiti:
• Laurea in Medicina e Chirurgia e Iscrizione all’Ordine dei Medici
• Esperienza pregressa nel ruolo
• Si valutano le seguenti specializzazioni mediche:

✓ ANESTESIA RIANIMAZIONE
✓ CARDIOLOGIA
✓ DERMATOLOGIA
✓ GERIATRIA
✓ MEDICINA FISICA E RIABILITATIVA
✓ MEDICINA INTERNA
✓ NEUROLOGIA
✓ ORTOPEDICO
✓ PNEUMOLOGIA
✓ PSICHIATRIA

La ricerca è rivolta a entrambi i sessi (Legge 903/77 e art.8 D.lgs 196/00).

Tipologia contrattuale:
• Stipula di contratto libero professionale con P.IVA o assunzione a tempo indeterminato
• Impegno orario settimanale da concordare con la struttura
• Compenso in linea con i valori della Sanità Pubblica
• Piattaforma scontistica riservata ai dipendenti/collaboratori KOS
• Percorsi di formazione aziendale attraverso la nostra Kos Academy

Sedi di lavoro:

TRENTINO ALTO ADIGE
• Santo Stefano Riabilitazione Ospedale San Pancrazio ad Arco di Trento (TN)

LOMBARDIA
• Residenze Anni Azzurri site a Milano e hinterland
• Santo Stefano Riabilitazione Villa San Giuseppe ad Anzano del Parco (CO)
• Santo Stefano Riabilitazione a Mede (PV)

VENETO
• Santo Stefano Riabilitazione Villa Margherita ‘ad Arcugnano (VI)

EMILIA ROMAGNA
• Clinica Specialistica Psichiatrica Villa Azzurra a Riolo Terme (RA)
• Santo Stefano Riabilitazione Centro Cardinal Ferrari a Fontanellato (PR)

TOSCANA
• Residenza Anni Azzurri sita a Campi Bisenzio (FI)

MARCHE
• Casa di Cura Villa dei Pini a Civitanova Marche (MC)
• Santo Stefano Riabilitazione Villa Fastiggi a Pesaro
• Centro Ambulatoriale Santo Stefano Riabilitazione a Macerata

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Informatore scientifico del farmaco - varie sedi

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Sede: Latina
Modalità: Area di competenza territoriale
Tipologia di Contratto: tempo indeterminato tramite agenzia (staff leasing)
(livello B1 CCNL Chimico farmaceutico, RAL da definire sulla base della reale esperienza del candidato)

Mansioni:

Effettuare una dettagliata analisi dell'area assegnata in termini di contatti e segmentazione, in base alla quale definire il piano operativo;
Tradurre in adeguati programmi le linee guida indicate, stabilendo ed identificando le priorità operative;
Porsi in maniera proattiva verso le esigenze di conoscenza e approfondimento di contenuti scientifici relativi al prodotto di appartenenza, interfacciandosi, laddove necessario con i diversi ruoli o funzioni aziendali competenti;
Svolgere l'attività di informazione medico scientifica nel rispetto delle strategie aziendali, assicurando il rispetto della normativa (D.Lgs. 219/2006, codice deontologico di Farmindustria) e delle procedure aziendali di pertinenza, inclusi gli obblighi di farmacovigilanza, verificando poi la riuscita del processo di informazione attraverso gli strumenti dedicati (iConnect), ed elaborando la conseguente reportistica;
Gestire i contatti con le strutture ospedaliere al fine di favorire l’ingresso del prodotto assegnato.

Completano il profilo:

ottima predisposizione ai rapporti interpersonali,
capacità di lavorare per obiettivi e di organizzarsi in autonomia.
La precedente esperienza in mansione analoga costituirà titolo preferenziale.

Titolo di Studio: Laurea magistrale in medicina e chirurgia, scienze biologiche, chimica con indirizzo organico o biologico, farmacia, chimica e tecnologia farmaceutiche o medicina veterinaria o, in alternativa, Diploma Universitario in Informazione Scientifica del Farmaco.

Si offre: strumentazione professionale in dotazione (pc, smartphone, auto aziendale).

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Project Specialist

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Location: Home-based Italy (preferred big and well-connected cities, usually Milan or Rome)
Work mode: Ability to travel if necessary preferred (approximately 5%)
Contract: Permanent

Job summary:
The Project Specialist performs administrative and supportive activities assigned by the Project Lead to ensure the contracted services and expectations are carried out by the project team in accordance with executed contracts and the customers’ expectations.

Job responsabilities:

Set-up, maintain and/or close out project files and study information ((e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems.
Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure.
Maintains timely and effective communication among team members and site staff. Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. May contact site staff as needed for critical information.
Provide administrative support to Project Leads and functional leads.
Ensure all study documents are archived based on the appropriate guidelines and policy.
Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues.

What we’re looking for:

Associates Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience
Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
Strong organizational skills
Ability to manage time and work independently
High proficiency with full MS Office Applications
Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
High level of competence in English language

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Informatore Medico Scientifico In P.Iva – Bari

Regulatory Affairs - (RM)

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La divisione specializzata Adecco Life Science ricerca un\una: REGULATORY AFFAIRS

Stiamo collaborando con importanti aziende farmaceutiche che ci hanno chiesto di ricercare nella zona di Roma, in particolare a Pomezia, dei Regulatory Affairs in diverse specializzazioni:
- Medical Device
- API
- Farmaco

Responsabilità:
La risorsa svolgerà le seguenti attività:

La risorsa dovrà occuparsi principalmente di attività burocratico-documentali e della gestione di aspetti tecnici;
Redazione e aggiornamento di DMF;
Supporto tecnico al cliente;
Registrazioni dei prodotti in paesi UE ed extra UE;
Presentazione della documentazione normativa in tutto il mondo;
Redazione della documentazione tecnica (Technical File e Product Information File);
Ottenimento certificazione CE per i prodotti;
Gestione normativa delle modifiche;
Conoscenza dei principali applicativi Office e dei più comuni software gestionali (SAP, PMX).

Requisiti:

Laurea in Farmacia, Farmacia Chimico-Tecnologica o altro attinente scientifico;
Costituiscono titolo preferenziale la laurea magistrale in discipline regolatorie e/o pregressa esperienza nell'ufficio regolatorio di aziende farmaceutiche, anche se di breve durata (es. 6 mesi);
Il conseguimento di un Master in Regulatory Affairs sarà considerato un plus;
Buona conoscenza dell'inglese;
Conoscenza di base della struttura organizzativa di un'azienda farmaceutica;
Conoscenza di base della legislazione italiana ed europea;
Conoscenza di base delle GMP;
Conoscenze di base delle tecniche farmaceutiche e analitiche;
Competenze dei sistemi informatici;
Buone capacità di lavoro in team, precisione e organizzazione;
Attitudine positiva;
Buona gestione del tempo (rispetto delle scadenze, in base alle priorità assegnate);
Curiosità e pensiero critico;
Agilità e capacità di ascolto;

Benefit:

Contratto alle dirette dipendenze dell'azienda (commisurato all'esperienza maturata);
Formazione professionale;
Opportunità di entrare in un contesto altamente strutturato e di respiro internazionale.

Link all’annuncio Adecco: https://go0.it/ZxWyX

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Manager, Business Insights & Analytics Hematology

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Location: Rome (Italy)

Job Description:
We are now recruiting a Manager, Business Insights & Analytics Hematology (Office Based in Rome), who will be responsible for using analytics tools triangulating different data sources, business performance reporting, and forecasting to answer key business questions for the Hematology TA. The Manager Business Insights & Analytics Hematology will collaborate with the Senior Manager, BI&A Hema & IO in identifying appropriate Market Research to holistically answer questions for business stakeholders and supports the development of the integrated insights plan.

Key Duties and Responsabilities:

Under the supervisor of the Senior Manager, BI&A Hema & IO, who is ultimately responsible for the for the Hematology TA, designs and implements analytics, performance management reporting, and forecasting for planned and ad-hoc needs.
Collaborate with the Senior Manager, BI&A Hema & IO to effectively influences all senior management stakeholders (BUDs, Marketing, Sales, Medical, Market Access, SIBO and Finance)
Synthesize from data from multiple sources to develop realistic, insightful, and actionable recommendations; presents results of strategic projects (i.e., Resource Allocation, Key Driver Analysis, In-Line Forecasts) in a coherent, meaningful way.
Support the Associate Director, Business Insights & Analytics in drawing conclusions from complex situations to recommend and execute a course of action in both a timely and decisive manner.
Collaborate with the Senior Manager, BI&A Hema & IO to the development and deployment of innovative BI&A approaches, therapeutic area learnings and best practices within the global BI&A structure.
Support Worldwide, other geographies and functional teams for efficient sharing and strategic adoption of learnings and capabilities
Apply global standards, models, and templates to drive high standards and consistency in analytics.
Collaborate with the Senior Manager, BI&A Hema & IO during the Projection forecasting process as well as the annual market planning and budgeting process.
Proactively manages the flow of planned and ad hoc requests to internal and external resources.
Identify relevant data sources and coordinates acquisition with the Senior Manager, BI&A Hema & IO; utilizes subnational data to inform decisions.
Collaborate with and supervises the third-party team members.

Qualifications, Knowledge and Skills required:

Master’s Degree in Economics / Engineering.
3+ years of pharmaceutical/related market experience, including working knowledge of various analytical capabilities
Ability to leverage large, multi-dimensional data sets to drive business decisions
Ability to frame issues and present to business stakeholders
Ability to work in matric and complex organizational environment
Ability to interact with marketing management, understanding, anticipating, and fulfilling their insight/analytical information requirements
Experience in the application of forecasting, advanced analytics and reporting techniques to solve business problems
Preferred: Knowledge of the pharmaceutical industry and healthcare marketplace dynamics
Working knowledge of Microsoft Excel and PowerPoint as well as secondary healthcare data
Fluent in English and Italian both written and spoke

L’appartenenza alle categorie protette, lg. 68/99 costituirà titolo preferenziale.

_ _ _ _

Ti sei riconosciuto nei requisiti?

Candidati oggi stesso!

Al termine dell'evento online del Bio Pharma Day i tuoi dati e cv verranno inviati al team di reclutamento che valuterà il tuo profilo (qualifiche, competenze ed esperienza) ed esaminerà il tuo CV per determinare se le tue competenze ed esperienze corrispondono al profilo professionale. I candidati selezionati, che corrispondono al profilo, saranno contattati per un colloquio.

What’s important to us? Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:

Passion: Our dedication to learning and excellence helps us to deliver exceptional results.
Innovation: We pursue disruptive and bold solutions for patients.
Urgency: We move together with speed and quality because patients are waiting.
Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments.
Integrity: We demonstrate ethics, integrity, and quality in everything we do for patients, customers, and colleagues.
Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential.

We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve.

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Customer Service Representative - Pomezia (RM)

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Location: Pomezia (RM)
Work Mode: on site & smart working
Contract: temporary contract (12 months)

Responsabilities:

Be accountable for outbound calls to the assigned customers in order to offer alternative products in substitution;
Manage the replacement offer and the order processing, following guidelines and procedures;
Track and report all the interactions with the customers recording on the dedicated system all the orders, changes, cancellations, delivery dates, application of products, and pricing;
Responsible for summarizing and analyzing data and reporting of results;
Collaborate with the sales force communicating with scheduled timing results of all interactions with customers.

Requirements:

Proficient computer skills, including Microsoft Office Suite,
Fluent English,
Excellent written and verbal communication skills,
Interpersonal and teamwork skills,
Ability to adapt to new systems and procedures,
Knowledge of SAP will is a plus.

Degrees: Laurea in qualsiasi facoltà

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QC Analyst

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Location: Latina Scalo (LT) - Lazio
Contract: 6 months of paid Internship

Main Activities - QC Microbiology Analyst:

Daily use and control of the main laboratory equipment (chromogenic kinetic, isolator, biolog);
Microbiological analysis of raw materials, semi-finished and finished products according to current analytical methods;
Sterility testing within the isolator system;
Microbiological validation activities;
Issuance and review of laboratory documentation;
Preparation and sterilization of culture medium;

Main Activities - QC Chemical Analyst:

Chemical analysis of raw materials, semi-finished and finished products according to current analytical methods or Pharmacopoeias;
Daily use and control of the main laboratory equipment (HPLC, UPLC, UV, SoloVPE, KF, IR);
Evaluation of analytical results obtained;
Drafting of GMP documentation;
Proper handling and use of reagents and laboratory standards;
Use of major data processing and management software (Empower, Totalchrom, UV WinLab ES, Excel, LIMS).

Main Requirements:

MA degree (CTF/Chemistry/Biology/Biotechnology)
Available on working on shifts
English working knowledge
Great can-do attitude

At BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. We respect the diversity, the different backgrounds and experiences and provide equal opportunity for all. We are BSP!

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QC Chemistry Analyst

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Location: Malta Office - APL Swift Services (Malta) Ltd, HF26, Hal Far Industrial Estate, Birzebbugia BBG 3000 Malta

Objectives:

To perform testing of finished goods according to specified procedures and in compliance to EU GMP.

Tasks and Responsibilities:

To prepare, standardise and label stock solutions and laboratory reagents as required.
To routinely monitor and analyse the water supply according to Company procedures.
To ensure that all equipment, apparatus and premises of the QC Department are functional and suitable for their intended use, by performing maintenance and calibration as instructed. Apparatus should
be handled in the proper manner and not in a way which may be detrimental to its function.
To assist outside contractors in performing calibrations throughout the company and keep records of these according to standard procedures as required.
To report LIRs and deviations in a timely manner.
To work out calculations pertaining to analysis and produce the relevant documentation in association always in compliance to EU GMP. To ensure proper filing and easy retrieval of all documentation and
records pertaining to the QC Department.
To assist the immediate superiors in problem solving exercises and other exercises aimed at improving quality and efficiency.
To perform laboratory equipment qualification and calibration accordingly to a predetermined schedule.
To perform method validation as required.
To maintain records of stocks of reagents, equipment spares and reference standards in such a way as to report when re-ordering is due.
To follow and document (record) precisely all activities as described in the relevant Standard Operating Procedures (SOPs), Test Methods and Protocols.
To perform all duties as laid down and any additional duties as may be allocated from time to time by the QC Manager or delegate in a proper professional manner and in the best interest of APL Swift
Services (Malta) Ltd.
Executes product testing as per the approved methods of analysis.
Inputs generated lab data in LIMS

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Manufacturing Associates for Process Operators

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Employer: Fujifilm Diosynth Biotechnologies
Location: Hillerød (Denmark)
Contract: Permanent position - Full-time
Date of employment: As soon as possible

Job description:
FUJIFILM Diosynth Biotechnologies is currently expanding its capacity to support the large-scale production by adding 14x20,000L bioreactors and three downstream processing lines in Hillerød. They are looking for Manufacturing Associates (Process Operators) to support the biopharmaceutical production operations for the two departments of the Drug Substance Manufacturing Unit (DSM): Upstream and Downstream. These are covering different steps in the biopharmaceutical production such as Media/Buffer preparation, CIP, SIP of equipment, expansion of cell cultures, and purification via multiple column steps.

This is an excellent opportunity to join our company at a pivotal time of growth and be part of an exciting journey.

Work schedule:
You will work on a day or night shift, 7 days during a 14-day period, including every other weekend. Please add in your application which shift or shifts you prefer:
- Day 1: 06:00 – 17:04
- Day 2: 07:45 – 18:49
- Night 1: 18:30 – 04:43
- Night 2: 20:05 – 06:18

- Week 1: Monday, Tuesday, Friday, Saturday and Sunday
- Week 2: Wednesday and Thursday

Please be aware that your first 6 weeks will consist of a training period, both onsite and offsite.

Task:

Execution and revision of cGMP documents
Handling and completion of batch documentation
In-process sampling and analytical measurements
Execution of validation protocols
Read and understand work instructions (in English)
Training new colleagues
Reporting deviations
Possibility of being a part of different projects such as, process optimization, red lining SOPs, 5S and continuous improvement

Qualifications:

Bachelor or Master degree relevant for Biologics Manufacturing
Experience as a process operators
preferable with experience from a similar pharmaceutical production company or similar regulated businesses OR a Life Sciences Graduate
It is a plus if you have experience with cGMP and/or SOPs or knowledge of chromatography and filtration processes.

You will get the opportunity to customize your development plan in agreement with your manager based on your wishes and qualifications.

We are hiring for attitude, so we are looking for people who have a lot of drive and proven interest with working under GMP and enjoy working with numbers, math and IT tools. You are very quality-oriented and thorough. You are proactive, responsible, organized and able to take ownership of tasks. Furthermore, you are a good team player who thrives on setting a good example. You must be keen on learning new things, and the first period will of course include thorough training.

---

About the company:
FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

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Fisioterapisti - varie sedi Italia

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Requisiti:
• Laurea in Fisioterapia ed iscrizione all’albo
• Gradita sperienza pregressa nel ruolo
La ricerca è rivolta a entrambi i sessi (Legge 903/77 e art.8 D.lgs 196/00).

Tipologia contrattuale:
• Stipula di contratto libero professionale con P.IVA o assunzione a tempo determinato
finalizzato alla stabilizzazione
• Compenso in linea con i valori della Sanità Pubblica
• Piattaforma scontistica riservata ai dipendenti/collaboratori KOS
• Percorsi di formazione aziendale attraverso la nostra Kos Academy

Sedi di lavoro:

LOMBARDIA
• Residenze Anni Azzurri site a Milano e hinterland

PIEMONTE
• Residenze Anni Azzurri site in provincia di Torino, Cuneo, Asti, Vercelli e Novara

VENETO
• Santo Stefano Riabilitazione Villa Margherita ad Arcugnano (VI)

TOSCANA
• Residenza Anni Azzurri Beato Angelico a Borgo San Lorenzo (FI)

MARCHE
• Santo Stefano Riabilitazione a Porto Potenza Picena (MC)
• Santo Stefano Riabilitazione Villa Adria ad Ancona
• Santo Stefano Riabilitazione Residenza Dorica ad Ancona
• Santo Stefano Riabilitazione a Macerata Feltria (PU)
• Santo Stefano Riabilitazione Venerabile Marcucci ad Ascoli Piceno

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GMP Scientist - Pharmaceutical Development

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Employer: Lundbeck
Location: Valby, Denmark
Contract: fixed-term (1 and helf year)

Job description:
Do you want to be part of a team that supports Lundbeck’s development pipeline by delivering small molecule drug products to clinical trials? Then you could be our new GMP Scientist working with various tasks supporting our clinical manufacturing and deliveries to clinical trials, combining your scientific understanding with the guideline requirements.

This temporary position could be a great start to a professional career in the pharmaceutical industry or a learning opportunity for you to change track and attain insight into the GMP manufacturing set-up and R&D value chain as well as the development interface of the pharmaceutical industry. It is a great chance to work alongside dedicated colleagues, who support the development of innovative treatments that improve the lives of people living with brain diseases.

As GMP Scientist, you will support our GMP clinical manufacturing in collaboration with various CMOs, typically based abroad.

Your key tasks and responsibilities:

You will be responsible for various steps along the process from ensuring timely delivery of materials;
Reviewing production documentation;
Supporting deviations;
Collaborating with the internal scientists and the CMO on setting up the project specific manufacturing requirements;
You will learn how to navigate requirements for the dosage forms used in Lundbeck’s small molecule pipeline projects, e.g., oral solutions, capsules, and tablets;
And how to apply this knowledge in specific deliverables for the manufacturing campaigns.

Requirements:

You hold a MSc within Pharmaceutical Sciences, Engineering or another relevant scientific discipline.
You are structured and possess a general understanding of GMP requirements and regulations in pharmaceutical industry.
Insight to manufacturing processes related to small molecules will be seen as an asset.

In addition:

You enjoy working in cross functional teams and with external partners such as CMOs
You bring a positive mindset and embrace challenges when obstacles occur
You are fluent with spoken and written English.

Your future team:
Pharmaceutical Development is part of CMC (Chemistry, Manufacturing & Controls) and our office is located in Valby. You will join our team of 13 colleagues who take pride in combining deep scientific insight with the requirements for the individual projects. As our GMP scientist, you will be part of the group responsible for ensuring all GMP related processes are followed when we collaborate with our CMOs on manufacturing bulk drug product.

Our team culture is characterized by collaboration, curiosity and responsible proactiveness. We have a very great collaboration across the different roles in the department, and you will be responsible for supporting that our end products are manufactured in timely manner and according to all rules and regulations.

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About Lundbeck

Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research.

We are tirelessly dedicated to restoring brain health, so every person can be their best. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options.

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Junior Engineer

Associate Manufacturing Operator - Latina

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Sede: Latina
Modalità: on site
Tipologia di Contratto: contratto di somministrazione iniziale di 3 mesi con la possibilità di proroghe e sviluppi futuri.

Mansioni:
All’interno del reparto di manifattura farmaceutica ti occuperai:

del caricamento della materia prima, della miscelazione, della granulazione, e della filmatura del prodotto

All’interno del reparto di confezionamento ti occuperai:

della gestione dei macchinari produttivi (blisteratrice, astucciatrice) e del cambio formato

Gestendo in entrambi i casi anche:

eventuali piccoli interventi di inceppamento linea
l’inserimento dei parametri produttivi nel sistema informatico
il monitoraggio dell'andamento della produzione secondo gli standard aziendali operando nel rispetto delle GMP.

Completano il profilo:

precedente esperienza in ambito manifatturiero, preferibilmente del settore farmaceutico, cosmetico o alimentare,
atteggiamento di serietà, operosità e capacità di relazionarsi in ambienti multinazionali e strutturati.

Titolo di Studio: Diploma di scuola secondaria superiore, ad indirizzo preferibilmente tecnico scientifico.

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Job Project Engineer - Latina

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Sede: Latina
Modalità: on site
Tipologia di Contratto: inserimento diretto a tempo indeterminato, livello e retribuzione commisurate alla reale esperienza del candidato, ottime opportunità di crescita professionale.

Mansioni:

Gestire i progetti di ingegneria relativi all’ installazione ed all’ottimizzazione di equipment ed impianti, gli adeguamenti delle capability delle aree GMP e non-GMP e le attività relative a progetti di espansione della capacità produttiva derivante dalla realizzazione di nuove aree di manifattura;
Rispettare gli obiettivi di progetto in termini di tempistiche e di ottimizzazione del rapporto costi benefici, e redarre la documentazione tecnica di progetto in collaborazione con l’ufficio acquisti, che verrà supportato da un punto di vista tecnico nella gestione dei fornitori;
Elaborare la reportistica di andamento del progetto;
Effettuare i test di collaudo e supportare le attività di qualifica.

Completano il profilo:

L’esperienza di almeno 1 anno in ruolo analogo;
La conoscenza delle norme ASME, GMP e GEP;
Fluente conoscenza della lingua inglese.

Titolo di Studio: Laurea in Ingegneria Chimica.

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Informatore Scientifico del Farmaco - tutta Italia

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Sede: Si valutano candidature per tutta Italia

Ruolo:
L'Informatore Scientifico del Farmaco (ISF) è la figura aziendale che si occupa di presentare agli operatori sanitari i medicinali ed i prodotti farmaceutici del Gruppo Menarini. L'ISF fornisce alla classe medica informazioni di carattere tecnico-scientifico sulle caratteristiche terapeutiche dei farmaci, sulle modalità d'uso e sul loro corretto utilizzo.

Requisiti:

Neolaureati in discipline scientifiche secondo quanto stabilito dal D.Lgs. 24 aprile 2006, n. 219 - art. 122: (Medicina, Farmacia, Scienze Biologiche, Chimica e Tecnologia Farmaceutica, Chimica ad indirizzo organico o biologico, Veterinaria), ovvero neodiplomati universitari in Informazione Scientifica sul Farmaco.
Professionisti dell’Informazione Scientifica del Farmaco con esperienza, maturata in primarie Società farmaceutiche.

Si offre:

Inquadramento secondo quanto previsto dal C.C.N.L. vigente;
Retribuzione di sicuro interesse, commisurata alle esperienze maturate;
Auto aziendale e telefono cellulare;
Aggiornamento professionale continuo;
Rimborsi spese a piè di lista

I CV ricevuti saranno trattati in ottemperanza ed ai sensi del D.Lgs. 30 Giugno 2003, n. 196 “Codice in materia di protezione dei dati personali”.
Ai sensi del D.Lgs. 11 Aprile 2006, n. 198 (“Codice delle pari opportunità tra uomo e donna”), la presente offerta di lavoro si intende rivolta ai entrambi i sessi.

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Commissioning & Qualification stageur

Product Stewardship Specialist – Pioltello (MI)

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Job Location: Pioltello (MI)

We offer:

For a maternity leave replacement;
Initial 2 month contract by Kelly Services;
Smartworking

Mission and responsibilities:
The selected person will be responsible for the following activities:

Verify new products for the Italian market in compliance with local law for chemical registration and evaluation, labelling and waste, but also all the local legislations impacting products commercialization;
Support handling local customer requests regarding Product Stewardship with the help from European Business PS and European Subject Matter Experts;
Monitor and assess impact of relevant emerging Local Regulatory Requirements and Trends.

Qualifications and experiences:

Scientific University Degree;
Educational and technical background;
Fluent in English (written and spoken).

Attributes and skills:

Project management;
Ability to prioritize and execute;
Good communication skills;
Networking capabilities.

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Assistente Sociale - Lombardia

Technology Transfer Specialist - Latina

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Sede: Latina
Modalità: on site
Tipologia di Contratto: inserimento diretto a tempo indeterminato, livello e retribuzione commisurate alla reale esperienza del candidato.

Mansioni:

Messa a punto del processo produttivo e dell'industrializzazione di nuovi prodotti (operazioni intracompany e intercompany);
Rispetto dei tempi e analisi del budget di progetto nell'ambito del lifecycle management del prodotto;
Emissione del TTP con il coinvolgimento delle funzione preposte alla compilazione del technology transfer report.

Completano il profilo:

la pregressa esperienza in ruolo analogo, o in ruoli di process o cleaning validation,
la fluente conoscenza della lingua inglese,
una spiccata predisposizione al problem solving,
la capacità di interagire a più livelli con interlocutori diversi.

Titolo di Studio: Laurea magistrale in Ingegneria Chimica, Chimica e Tecnologie Farmaceutiche od affini.

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Clinical Trial Manager

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Sede: Milano
Modalità: ibrida
Tipologia di contratto: tempo indeterminato

Descrizione mansioni:
Gestione di studi clinici internazionali promossi dal Cliente:

verifica di tutti i processi legati alla conduzione degli studi clinici, per assicurarsi che siano svolti in accordo alle procedure concordate, alle normative applicabili e alle tempistiche stabilite;
coordinamento dei diversi ruoli aziendali coinvolti negli studi clinici per garantire il corretto svolgimento delle attività;
verifica della correttezza della documentazione generata all’interno di uno studio clinico;
verifica dello stato di avanzamento dei progetti rispetto al budget assegnato.

Oversight management delle CRO internazionali coinvolte negli studi clinici promossi dal Cliente, mediante il:

coordinamento delle risorse assegnate,
la verifica del rispetto delle tempistiche prestabilite e del budget assegnato.

Lauree: discipline scientifiche

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Quality Control Assistant

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Location:

As a part of the Quality Control department of the API - Plant (Active Pharmaceutical Ingredient) we are hiring a Quality Assurance Associate.

Your key tasks and responsibilities:

Performs chemical and microbiological analysis according to approved documentation (procedures, methods);
Uses analytical techniques such as: GC, HPLC, UV, FTIR;
Develop new analytical methods;
Prepare analytical method validation protocols;
Supports the QC Manager in reviewing procedures;
Respects laboratory procedures and contributes to their improvement.

Requirements:

Master of Science (Chemistry, CTF, Pharmacy, Industrial Chemistry);
3-5 years experience in GMP chemical-pharmaceutical analysis laboratory or API companies;
Knowledge of pharmaceutical regulations and guidelines (GMP, GLP, ICH);
Excellent knowledge/use of calculation and writing software (MS Word, MS Excel);
Knowledge of Data Integrity issues;
Excellent knowledge of English.

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Quality Assurance Intern

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Employer: Novo Nordisk
Location: Gentofte, Denmark
Role: General Management and Administration
Contract: 6 months remunerated Intership (if your educational track allows) - Full-time
Working hours: 18 to 37 hours per week
Start Date: January 2024

Are you interested in ensuring quality in the challenging field of biotechnology and rare diseases? Are you looking for the opportunity to work alongside experienced QA specialists and interact with stakeholders across our organization? If this resonates with you, join us as our new Intern in the Biotech & Rare Diseases, Quality Assurance team at Novo Nordisk to gain valuable learning experiences and bring fresh insights to our team. Apply now!

The Position:
As our intern, you'll collaborate with us on various tasks related to training documentation, system approvals, project support, and a variety of ad hoc tasks. Our work culture thrives on positivity and energy, and we place a strong emphasis on networking and teamwork.
This internship is an excellent position to begin a career in quality assurance. Please note that students must be enrolled at a university through the entire internship period. The working hours are flexible from a minimum of 18 to a maximum of 37 hours a week enabling you to combine an internship with lectures at university, project work, or writing your Bachelor/Master’s thesis.

Qualifications:
You are a Student who is currently enrolled in a university program (Bachelor's or Master's level) within the preferred fields of study:

Health and Medical Sciences, Pharma, Engineering, Business, or other relevant disciplines.

To succeed in this role, you need:

Experience or interest in system and process optimization with some group project work experience
Structured mindset with strong analytical and organisational skills in your deliverable timeline and project management
Proficiency in both spoken and written English

Preference (nice to have):

Familiarity with IT tools, such as SharePoint and Office 365
Knowledge of Danish language

We are seeking an individual eager to learn and contribute an individual who aligns with our dedication to quality processes and project management. You are curious by nature, thrive in a versatile environment, and are ready to be part of our ongoing effort to improve our high standards, including ensuring that new ways of working are implemented smoothly. Join us and together embark on a journey of professional growth within our esteemed organization.

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The Company
About the Departement:
Biotech & Rare Diseases, QA QC, MDev, and Business Support consist of over 30 committed colleagues. In collaboration with our stakeholders, we strive each day to maintain consistent quality oversight and high-quality standards.
We play a pivotal role in the quality assurance of QC and the integration of emerging technologies into production. We also offer support across the BRD sites in areas such as process management, inspections, SAP, digitalization, and the execution of numerous improvement projects.

Working at Novo Nordisk:
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees.
Together, we go further. Together, we’re life-changing.

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CRM Operator

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Context:
The person will be inserted in the Global Field Force & Marketing Systems Management structure, and will be part of the Implementation & Adoption Team.
The CRM Operator is the CRM subject-matter expert and, as such, the point of contact for all users of the system.
He/She will lead efforts for the continued education and support of the tool, ensure data quality and integrity, improve knowledge base of the tool and safeguard adherence to Global processes, as well as assist in resolving system-related issues.

Main activities and responsabilities:

Be an advocate for the CRM platform.
To contribute to knowledge sharing across the regional teams and countries.
To lead communication for platform and process changes.
To draw up documentation (mainly in English) to illustrate how to use the CRM system transferring policies and correct ways of working driving the consistent usage of the system.
To prepare specific user guides, training materials or video tutorials to better explain specific system functionalities.
To organize and hold training sessions on processes to increase efficiency of usage.
To cooperate in the implementation of the CRM system in new countries/companies.
To plan the roll-out of new modules in the affiliates.
To assist CRM end-users in their daily operations.
To maintain the Company structure of all Italian Companies creating/dismissing new users, managing the territories and the doctors’ assignment.
Ability to assist in trouble shooting of ad hoc issues.
Escalate reoccurring technical issues to the relevant support team.
Be the voice for process and platform improvements with the development area collecting countries' specific needs.

Job requirements:
Education

University degree with preferable scientific background.

Qualification and skills

Good knowledge of Google Suite and Office Suite applications.
Basic knowledge of SQL language.
Good analytical skills.
Ability to manage several projects at one time with clear identification of priorities.
Proactive attitude to drive projects to completion, spirit of initiative.
Strong communication properties and interpersonal skills.
Attitude to team working.
Strong motivation.

Language skills

Fluent in English (spoken and written).

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QC Analyst - Latina, Promezia (RM)

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Sede: Latina, Pomezia (RM)
Modalità: on site, con disponibilità al lavoro su 2 turni di lavoro o a ciclo continuo
Tipologia di Contratto: forma contrattuale e livello retributivo commisurati alla reale esperienza del candidato

Mansioni:

Esecuzione dei test analitici su prodotti chimici e materie prime attraverso attività quali cromatografia liquida (HPLC), gascromatografia. titolazione potenziometrica, spettrografia, cromatografia su strato sottile (TLC);
Assicurazione della calibrazione giornaliera e periodica delle apparecchiature, approvvigionamenti e smaltimenti;
Documentazione del processo di lavoro e dei risultati dei test in conformità alle normative GMP.

Completano il profilo:

Esperienza di almeno 6 mesi in ruolo analogo;
Caratteristiche personali di serietà, attenzione e capacità di operare nel rispetto dei ruoli.

Titolo di Studio: Laurea in discipline scientifiche quali chimica e tecnologie farmaceutiche, farmacia, chimica od affini.

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Biostatistics

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Employer: Genmab
Location: Copenhagen (Denmark), Utrecht (Netherlands) or Princeton (USA) - hybrid or remote.
Contract: Hiring level will be determined based on experience
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.

We are looking to expand our Biostatistics team with candidates at different levels in Denmark, US and the Netherlands.

Key responsabilities include:

Supporting the design, execution, analysis, interpretation, and reporting of clinical trials as well as communication of data evidence for Clinical Research & Development and Medical Affairs programs.
Supporting the statistical aspects of business-critical and/or regulatory commitments, provides input to program plans, and represent the Biostatistics function for cross-functional and intra-departmental teams or working groups.
Functioning as the lead statistician for assigned clinical projects such as a clinical trial, a compound in clinical development or an indication in a large clinical development program.
Representing Biostatistics in multidisciplinary teams responsible for assigned clinical projects and be accountable for all associated biostatistics deliverables.
Developing and maintaining advanced competences in statistical analysis, modelling and simulation and advanced trial designs
Performing management of in-house and/or outsourced biostatistical activities
Depending on hiring level, may engage with regulatory authorities on compound/indication level discussions.
Depending on hiring level, may represent the Compound Development Team/Genmab at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicable.
Depending on hiring level, may lead cross-functional teams indirectly on large scale projects/ processes.

Requirements:

You have a strong background in statistics corresponding to at least a Master’s degree.
For manager levels*: you have at least 2 years of experience within clinical or biostatistical research
For director levels*: you have at least 5-10 years of experience within clinical or biostatistical research and have comprehensive data analytic expertise based on a good understanding of statistical principles and a strong track record of applied experience leading to successful program support. You are effective in the use of relevant computational tools and apply high quality statistical methodology in assigned projects with demonstrated understanding of the disease/scientific/functional area and health authority requirements.
In-depth understanding of statistical issues in drug development
Experience in statistical analysis, modelling and simulation and adaptive trial designs
Experience with oncology clinical trials is an preferred
Proficient programming skills in statistical software, such as SAS and excellent oral and written communication skills including ability to communicate statistical problems and ideas clearly to both statistical colleagues and stakeholders from other functional areas
Ability to work independently as well as in a team
Confident, self-reliant, and a quick learner
Proactive and open minded
Ability to prioritize and work in a fast-paced and changing environment
Result and goal-oriented and committed to contributing to the overall success of Genmab

About You:

You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
You are a generous collaborator who can work in teams with diverse backgrounds
You are determined to do and be your best and take pride in enabling the best work of others on the team
You are not afraid to grapple with the unknown and be innovative
You have experience working in a fast-growing, dynamic company (or a strong desire to)
You work hard and are not afraid to have a little fun while you do so

---

About Genmab
Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep passion for innovation, and desire to transform cancer treatment and serious diseases.

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Terapista della Neuro e Psicomotricità dell'età evolutiva - Marche

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Requisiti:
• Laurea in Laurea in Terapia della Neuro e Psicomotricità dell'Età Evolutiva (T.N.P.E.E.)
• Iscrizione all’albo
La ricerca è rivolta a entrambi i sessi (Legge 903/77 e art.8 D.lgs 196/00).

Tipologia contrattuale:
• Stipula di contratto libero professionale con P.IVA o assunzione a tempo determinato finalizzato alla stabilizzazione
• Compenso in linea con i valori della Sanità Pubblica
• Piattaforma scontistica riservata ai dipendenti/collaboratori KOS
• Percorsi di formazione aziendale attraverso la nostra Kos Academy

Sedi di lavoro:

MARCHE
• Centro Ambulatoriale Santo Stefano Riabilitazione a Porto Potenza Picena (MC)
• Centro Ambulatoriale Santo Stefano Riabilitazione a Civitanova Marche (MC)
• Centro Ambulatoriale Santo Stefano Riabilitazione a Macerata
• Centro Ambulatoriale Santo Stefano Riabilitazione a Tolentino (MC)
• Centro Ambulatoriale Santo Stefano Riabilitazione a Camerino (MC)
• Centro Ambulatoriale Santo Stefano Riabilitazione a San Severino Marche (MC)
• Centro Ambulatoriale Santo Stefano Riabilitazione a San Severino Matelica (MC)

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PMO Specialist - Pomezia (RM)

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Location: Pomezia (RM)
Work Mode: on site & smart working
Contract: temporary contract (6/12 months) with the possibility of personal and professional growth. Level and salary will be defined on the candidate's real skills.

Responsabilities:

Ensure Project definition and due diligence assessment towards the target and ensuring vertical start up i.e., execute and implement Project ON TIME IN FULL for both time, cost, quality, and safety parameters in line with Supply Chain commitments to the markets and business;
Facilitate Project execution for the site in collaboration with technical design departments, R&D and regional project managers assigned;
Coordinate trial program execution, secure execution of trial and assessment, report and follow through on next steps (PIPO, Validation activities and Plant technical functions…);
Coordinating all Plant related activities to ensure project remains on track Monitoring and managing Plant related risks and opportunities;
Ensure coordination in the overall Project portfolio for the site (continuous improvement, new product introduction etc.), confirming appropriate resource allocation in accordance with global/regional/local business priorities;
Leads escalation process in case of deviations;
Manage cross functional teams.

Requirements:

2 years of experience in Manufacturing, Engineering or Project management is preferred;
pro-active governance,
structured approach to problem solving,
clear communication,
service-orientation,
good skills in data management and creation of digital tools for reporting,
fluent IN English.

Degrees: Laurea in Ingegneria, Supply Chain, Logistica o Business Administration

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Stage curriculare

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Il candidato scelto per lo STAGE CURRICULARE nella Direzione Strategy, Innovation & Business Operations, sarà attivamente impegnato all'interno di progetti funzionali e interfunzionali, volti a raggiungere il quadro di successo del dipartimento e a supportare il raggiungimento degli obiettivi di business di Bristol Myers Squibb, garantendo l'eccellenza nell'esecuzione.

Il candidato acquisirà:
> Eccellenti capacità analitiche
> Capacità di lavorare in team e in un'organizzazione a matrice complessa
> Capacità organizzative e gestionali, problem-solving, analisi del rischio
> Capacità di gestione delle relazioni esterne

Le attività comprendono:
- Launch excellence e modelli di G2M
- Sviluppo e ottimizzazione del processo di Account Management
- Pianificazione e analisi del sistema di incentivazione della field force (dalla stesura del piano al payout)
- Supporto allo sviluppo di un piano di comunicazione Omnicanale e dei Customer Engagement Journeys
- Altre attività crossfunzionali

Il candidato/a ideale avrà le seguenti caratteristiche:
- Prossimo conseguimento della Laurea (Magistrale o Specialistica – 5 anni) in INGEGNERIA o ECONOMIA o equivalente
- Prossimo conseguimento del Master
- Ottima conoscenza della lingua inglese
- Ottima conoscenza del pacchetto Office, utente avanzato di Excel e Power Point
- Analitico con attenzione ai dettagli, eccellenti capacità organizzative e capacità di prioritizzare con efficacia
- Attitudine a svolgere attività in modo indipendente e a confrontarsi in team cross-funzionali

Sede: Roma

What’s important to us
Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:

Passion: Our dedication to learning and excellence helps us to deliver exceptional results. Innovation: We pursue disruptive and bold solutions for patients.
Urgency: We move together with speed and quality because patients are waiting. Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments.
Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.
Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential.

We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve.

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Quality Assurance Stageur

Regulatory Compliance Specialist

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Location: Pomezia (RM)
Expected Travel: 0-10 %

Context:
The Regulatory Compliance Specialist, as part of the Quality Assurancce team, will interact with every level and group in the organization including corporate regulatory functions and external customers. The Specialist should be able to work independently without a set day-to-day schedule to ensure regulatory requirements are met. The Regulatory Compliance Specialist support the inital assessment of new internal and external project introduction in collaboration with Head of QA.

Main activities and responsabilities:

Using a broad base of knowledge and understanding of regulatory requirements assumes major responsibility for one or more major regulatory affair areas.
Identifies and defines contents for regulatory filings/dossiers. Leads the assembly and creation of these documents for their timely submission to regulatory authorities.
Maintenance of complex existing and new licenses/certificates as well asproduct approvals.
Responsible for overall compliance with regulatory requirements that apply to the product development cycle. Makes recommendations on how to achieve and maintain compliance.
Collaborates closely with manufacturing, engineering, quality control and other functions resolving regulatory compliance issues.
Regulatory impact assessment of internal technical and organisational changes.
Applies standard procedures and aquired knowhow to develop regulatory solutions of moderate to low complexity within the existing regulatory framework.
Collaborateswith individuals at all levels solving regulatory compliance issues, and recommends appropriate changes and measures.

Job requirements:
Education

Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, Biotechnology or related field.

Years of experience

At minimum 5 (five) year of relevant regulatory affairs experience in the biopharmaceutical industry

Qualification and skills

In-depth knowledge of European and/or international regulations and standards for Biologics and/or Pharmaceuticals.
Working knowledge of and ability to prepare regulatory documentation in compliance with regional regulatory requirements.
Familiarity with regulatory standards and demonstrating general knowledge of individual products/geographies.
Demonstrated ability to independently author sections of regulatory submission documents.
Qualified within the Regulatory function with a deep understanding of the basic principles, theories, practices, and concepts within the Regulatory function.
Recognition and awareness of gaps and potential solutions to close those gaps.
Ability to identify the adequate of sections and overall content for regulatory submissions.
Knowhow and practical experience in applying relevant software applications in order to effectively generate regulatory documents.
Demonstrated ability to communicate effectively at all levels both verbally and in writing.
Must be used to make timely and accurate decisions even under time pressure.
Demonstrated analytical thinking skills and the ability to solve complex problems

Language skills and level of proficiency

English- Proficiency Level

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Stage Medical Affairs – Milano

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Sede: Milano
Modalità: ibrida
Tipologia di contratto: Si offre uno stage curriculare o extracurriculare di 6 mesi, con possibilità di proroga.
E' previsto un rimborso spese e buoni pasto.

Sanofi, azienda multinazionale farmaceutica, sta ricercando per la propria sede di Milano una risorsa da inserire in stage all'interno del dipartimento Medical Affairs della Unit Specialty Care, in area Respiratoria e Gastroenterologica. La risorsa supporterà il Tutor di riferimento in tutte le attività legate al dipartimento, partecipando attivamente e ricevendo formazione on the job.

Le attività di cui si occuperà saranno principalmente:

Affiancamento e supporto nella definizione e lo sviluppo dei contenuti e dei materiali necessari all’attività del team di direzione medica;
Gestione in sinergia con il tutor di alcune attività e/o processi all’interno del piano medico con un focus su progetti scientifici, anche implementati dalla Direzione Medica Global;
Produzione in affiancamento al tutor di alerting di letteratura e preparazione newsletters periodiche;
Manutenzione file di tracciabilità delle attività (sia richieste di letteratura che informazioni);
Supporto alle attività di revisione e aggiornamento documentazione scientifica;
Supporto all’ideazione e alla creazione di nuovi strumenti per aggiornamento scientifico continuo del personale interno e per la valorizzazione del Medical Services all’interno e all’esterno dell’azienda;
Partecipazione a conference call e meeting aziendali;
Elaborazione di file Excel e presentazioni Power Point.

Requisiti:

Laurea in materie scientifiche (farmacia, CTF, biologia e affini);
Buona conoscenza di Excel e PowerPoint;
Ottima conoscenza della lingua inglese (livello C1);
Atteggiamento proattivo;
Buone capacità comunicative e di lavoro in team.

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Operatore GMP

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Adecco Lifescience ricerca una figura di Operatore di Produzione da inserire all'interno del dipartimento di produzione di un'importante azienda biotech e riporterà direttamente al Direttore di Produzione GMP.

Responsabilità:

Partecipa alle attività di produzione in conformità con le linee guida e GMP per la produzione di API;
Segue le Standard Operating Procedures;
Prepara, avvia e conduce le lavorazioni in ambiente sterile e non, esegue i controlli di processo e i campionamenti in riferimento alle norme di buona fabbricazione (GMP);
Prepara buffer e reagenti necessari nelle varie fasi di produzione;
Partecipa alle attività di produzione di Upstream e/o Downstream;
Partecipa alle attività di compilazione e revisione di documenti e Batch records di produzione in accordo alle cGMP ed alle procedure aziendali.

Competenze e requisiti:

Orientamento al dettaglio, altamente organizzato, affidabile e preciso nel lavoro
Buone capacità di comunicazione verbale e scritta, ottimo lavoro di squadra
Capacità di gestire le priorità e i flussi di lavoro
Versatilità, flessibilità e disponibilità a lavorare all'interno di priorità in costante cambiamento con entusiasmo.

Link all’annuncio Adecco: https://go0.it/P91zp

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Quality Assurance - Pomezia (RM)

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Location: Pomezia (RM)
Work Mode: on site
Contract: temporary contract (6/12 months) with the possibility of personal and professional growth. Level and salary will be defined on the candidate's real skills.

Responsabilities:

Supporting the investigative activities for the management of events and complaints within Quality Department, monitoring of the effectiveness of corrective actions (CAPA);
Participating in updating and drafting of Standard Operating Procedures (SOP);
Change control management for the implementation of new products;
Batch records review;
Daily inspections in production plant;
KPI monitoring for Quality System and continuous improvement activities;
Planning and participating to audit activities for Quality Assurance;
Finished product release in ERP system.

Requirements:

Independent level of English,
Good Office knowledge,
Good command of GMP & ISO (9001 e 13485),
Excellent interpersonal and team working skills,
Tenacity in achieving goals.

Degrees: Laurea in discipline scientifiche quali Farmacia, Chimica e Tecnologie Farmaceutiche o affini.

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Tecnico Controllo Qualità - Lodi

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Sede: Lodi
Moadalità: on site
Tipologia di Contratto: si offre assunzione diretta a tempo indeterminato e livello e retribuzione commisurate all'esperienza.

Mansioni:

Svolgimento di analisi di semilavorati e prodotti finiti attraverso l’utilizzo di pHmetro, titolatore, viscosimetro, osmometro, ecc. e strumentazione più complessa come Spettrometri UV-VIS, IR/HPLC/GC;
Esecuzione di attività di campionamento delle materie prime in ingresso e dei fluidi di processo.

Completa il profilo:

La pregressa esperienza di almeno un anno in ruolo e settore analogo e la conoscenza della strumentazione di settore (es. HPLC) e delle GMP,
capacità di lavorare in team.

Titolo di Studio: Diploma di Perito Chimico o Laurea in discipline scientifiche quali Farmacia, Chimica e Tecnologie Farmaceutiche, Biologia o affini.

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QA Scientist - QA Material Management

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Employer: AGC Biologics
Location: Copenhagen, Denmark

Job description:
Our team is growing, and we are looking for an experienced QA scientist to assist with Quality Assurance of Material Management
QA for Material Management is an important part of the Quality organization. You will be joining a diverse team of highly qualified colleagues, all with several years of experience within quality assurance.

This QA team is responsible for support of supply chain and QC in the areas for deviations, CAPA, change management, complaints, GMP documentation etc. in relation to material management. We also have oversight of the respective areas and assist with internal and external audits and regulatory inspections.

We are actively involved in the constant development within our field and the continuous improvement of our quality system. We aim at constantly ensuring that QC and manufacturing are in compliance with current standards for GMP production, i.e. EU GMP, 21 CFR and ICH guidelines.

The department has an open communication with focus on a high level of professionalism. We are open-minded and have a high support level to our colleagues in the rest of AGC Biologics A/S - and not least to our international customers. The QA Operations department is characterized by positive and proactive colleagues meeting deadlines through committed and friendly collaboration.

Tasks and Responsibilities:

As QA Scientist you will be involved in various daily operational tasks in a dynamic and challenging environment.
Your main responsibility will be to support Supply chain, Process Transfer and QC for late stage and commercial products, which includes:

Close collaboration with internal stakeholders
Review and approval of material specifications
Release of raw materials and disposables

We cooperate closely with the other departments in the organization in order to ensure that all quality related activities are carried out effectively and in compliance with cGMP.

Your Profile:

You have 2+ years of experience with Quality Assurance and/or material management.
Relevant academic background within pharmacy, biotechnology, biology, chemistry or similar.
Fluent written and spoken English.

You have experience within the following areas:

QA and/or Material Management
Requirements for commercial and/or late state clinical phase GMP manufacturing of biological intermediates, APIs and Cell Banks
QA oversight and guidance of staff
Experience with contract manufacturing and business understanding
Deviation handling including root cause investigations
Review and evaluation of cGMP documentation

In addition:
It is of utmost importance to have a self-motivating personality with a pragmatic attitude and approach to the daily work without compromising quality. The environment is dynamic and challenging, which requires the ability to find solutions, deliver on promises and give our customers a positive experience.

---

About the Company
AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services. Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.

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Infermieri - varie sedi Italia

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Requisiti:
• Laurea in Infermieristica ed iscrizione all’albo
• Disponibilità a lavorare su turni
La ricerca è rivolta a entrambi i sessi (Legge 903/77 e art.8 D.lgs 196/00).

Tipologia contrattuale:
• Stipula di contratto libero professionale con P.IVA o assunzione a tempo indeterminato
• Compenso in linea con i valori della Sanità Pubblica
• Piattaforma scontistica riservata ai dipendenti/collaboratori KOS
• Percorsi di formazione aziendale attraverso la nostra Kos Academy

Sedi di lavoro:

TRENTINO ALTO ADIGE
• Santo Stefano Riabilitazione Ospedale San Pancrazio ad Arco di Trento (TN)

LOMBARDIA
• Residenze Anni Azzurri site in provincia di Milano, Bergamo, Brescia e Monza
• Santo Stefano Riabilitazione Villa San Giuseppe ad Anzano del Parco (CO)
• Santo Stefano Riabilitazione a Casorate Primo (PV)
• Santo Stefano Riabilitazione a Mede (PV)

PIEMONTE
• Residenze Anni Azzurri site in provincia di Torino, Cuneo, Asti, Vercelli e Novara

LIGURIA
• Residenze Anni Azzurri site in provincia di Genova e Imperia

EMILIA ROMAGNA
• Santo Stefano Riabilitazione Centro Cardinal Ferrari a Fontanellato (PR)
• Clinica Specialistica Psichiatrica Villa Azzurra a Riolo Terme (RA)
• Residenza Anni Azzurri Idice a Castenaso (BO)
• Residenza Anni Azzurri Il Giardino a Bagnolo in Piano (RE)

TOSCANA
• Residenza Anni Azzurri a Campi Bisenzio (FI)
• Residenza Anni Azzurri Beato Angelico a Borgo San Lorenzo (FI)

LAZIO
• Residenza Anni Azzurri Parco di Veio a Roma

UMBRIA
• Santo Stefano Riabilitazione a Foligno (PG)

MARCHE
• Clinica Specialistica Psichiatrica Villa Jolanda a Maiolati Spontini (AN)
• Residenza Anni Azzurri Conero ad Ancona
• Santo Stefano Riabilitazione Villa Adria ad Ancona
• Residenza Anni Azzurri Valdaso a Campofilone (FM)
• Residenza Anni Azzurri S.Maria in Chienti a Montecosaro (MC)
• Residenza Anni Azzurri Villalba a Macerata
• Santo Stefano Riabilitazione a Macerata Feltria (PU)

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Fisioterapista Occupazionale - Marche

Tecnico di Neurofisiopatologia - Veneto

RMC (Raw Material Center) Scientist - Pomezia (RM)

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Location: Pomezia (RM)
Work Mode: on site
Contract: temporary contract (12 months) with the possibility of personal and professional growth. Level and salary will be defined on the candidate's real skills

Responsabilities:

Provide technical support, evaluating impact of changes related to the current raw material portfolio;
Work with other global leads and functions to develop and manage Global Change Controls for multiple raw materials;
Prepare lab batches of semi-solid and liquid products to assess equivalency;
Coordinate other business functions to evaluate the impact of the changes;
Support manufacturing investigations and provide general technical service to guarantee business continuity;
Manage project timelines.

Requirements:

Fluent English both spoken and written,
working knowledge of the Microsoft Suite, especially Excel,
ability to work independently and in a global environment,
excellent communication and presentation skills,
strong ability in term of problem-solving, complexity management and decision-making authority.

Degrees: Laurea in discipline scientifiche quali Farmacia, Chimica e Tecnologie Farmaceutiche o affini.

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Clinical Research Associate (CRA)

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Location: Home-based Italy (preferred big and well-connected cities)
Work mode: Ability to manage required travel of up to 75% on a regular basis
Contract: Permanent

Job summary:
The Clinical Research Associate I (CRA I) will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements. Requires guidance and oversight, while developing an understanding of the drug development and commercialization process.

Job responsabilities:

➤ Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.

➤ Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.

➤ For the Clinical Monitoring/Site Management Plan (CMP/SMP):

Assesses site processes.
Conducts Source Document Review of appropriate site source documents and medical records.
Verifies required clinical data entered in the case report form (CRF) is accurate and complete.
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture.
Verifies site compliance with electronic data capture requirements.

➤ May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.

➤ Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.

➤ Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.

➤ For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets.

➤ May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.

➤ Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.

➤ Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

➤ For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include:

Site support throughout the study lifecycle from site identification through close-out
Knowledge of local requirements for real world late phase study designs
Chart Abstraction activities and data collection
Collaboration with Sponsor affiliates, medical science liaisons and local country staff

What we’re looking for:

➤ CRA certification according to Ministerial Decree 15 Nov 2011
➤ Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
➤ Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
➤ Must demonstrate good computer skills and be able to embrace new technologies
➤ Excellent communication, presentation and interpersonal skills

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Manufacturing Associate for Expansion Project

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Employer: Fujifilm Diosynth Biotechnologies
Location: Hillerød (Denmark)
Contract: Full-time

Job description:
FUJIFILM Diosynth Biotechnologies is currently expanding its capacity to support the large-scale production by adding 14x20,000L bioreactors and three downstream processing lines in Hillerød. They are looking for Manufacturing Associates (Process Operators) to support the expansion project with the Commissioning Readiness of all Systems, to support Equipment Start-up and IOQ Testing.

This is an excellent opportunity to get extensive knowledge on the manufacturing equipment before we go into production in 2024.

The expansion project is set to end in approx. April 2024. When the project is finished you will automatically be offered a job opportunity in our new Drug Substance Manufacturing department covering - respectively – Upstream & Downstream. The two departments cover different steps in the biopharmaceutical production such as Media Preparation, CIP & SIP of equipment, growth of cell cultures, and purification via multiple column steps.

Work schedule:
During the first period of the project working hours will be mon-fri 08-16. But as we move further in to the project and into the testing phase we will go into shift work.

Task:

Support and review design deliverables incl. drawings, data sheets, specifications and engineering lists
Perform field walk-downs and Participate actively in weekly/monthly meetings and ensure timely updates
Ensure timely approval of Final reports and create training documents
Equipment testing
Trouble shooting

Qualifications:

Bachelor or Master degree relevant for Biologics Manufacturing
Experience as a process operators
preferable with experience from a similar pharmaceutical production company or similar regulated businesses OR a Life Sciences Graduate
It is a plus if you have experience with cGMP and/or SOPs or knowledge of chromatography and filtration processes.

You will get the opportunity to customize your development plan in agreement with your manager based on your wishes and qualifications.

We are hiring for attitude, so we are looking for people who have a lot of drive and proven interest with working under GMP and enjoy working with numbers, math and IT tools. You are very quality-oriented and thorough. You are proactive, responsible, organized and able to take ownership of tasks. Furthermore, you are a good team player who thrives on setting a good example. You must be keen on learning new things, and the first period will of course include thorough training.

---

About the company:
FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

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Site Contract Specialist

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Location: Home-based Italy (preferred big and well-connected cities, usually Milan or Rome)
Contract: Permanent

Job summary:
Administers and negotiates site contracts that support projects within Clinical Operations on a global scale, with oversight from the SSU Country Manager. Ensures site contract documentation is in compliance with sponsor and Company requirements. Works with internal and external team members to implement solutions for project and/or individual site contract related problems. Establishes strong working relationships with customer, internal project teams and sites. Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

Job responsabilities:

Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
Supports the SSUL to agree on country template contract and budget. Assists in producing site-specific contracts from country template.
Under supervision assist in negotiations of budget and contract with site and via Site Contracts Service Centre and SSUL lead with Sponsor until resolution of issues.
Assists with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
Assists in the reviews of contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
Assists SSU leads, Managers or other site contracts staff with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
Assists in providing and generating (amended) contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.
Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.
Collaborates with internal and external legal, finance, and clinical operations departments including communicating and explaining legal and budgetary issues for contract management tasks and issues.
Facilitates the execution of contracts by company signatories.
Supports the maintenance of contract templates and site specific files and databases.
Serves as communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

What we’re looking for:

BA/BS degree in related field or equivalent combination of education and experience
Clinical research, contracts, or related experience that includes working in a team-oriented environment preferred
Strong skills in Microsoft Office Suite, email, and voicemail
Strong organizational, presentation, documentation, and interpersonal skills
Ability to handle multiple tasks to meet deadlines in a dynamic environment
Good understanding of clinical trial process across Phases II-IV and ICH GCP Ability to interact effectively and appropriately with investigative site personnel
Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively
Ability to take direction from multiple individuals and set priorities accordingly
Ability to effectively communicate across multiple function groups (clinical team, PM, Director)
Demonstrated ability to work independently, as well as part of a team
Utilize problem-solving techniques effectively
Quality-driven in all managed activities
Flexibility and willingness to adapt to rapidly changing environment and learn/perform new functions
Strong computer skills, including Word, Excel

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Direttori Sanitari RSA - varie sedi Italia

Regulatory Affairs Junior Consultant

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Sede: Latina (LT) e/o da remoto

Tipologia di contratto: Tempo determinato – Full Time
L’inquadramento e il pacchetto retributivo saranno commisurati all’esperienza del candidato.

Responsabilità:

Gestione delle procedure di labelling e delle procedure centralizzate Europee (approvazione e/o variazione di nuovi prodotti in linea con le indicazioni provenienti dall’European Union Product Information (EUPI));
Coordinamento delle attività di traduzione dei documenti di provenienza EUPI tra fornitori esterni (centrali o locali) e team interni, garantendo la compliance e l’accuratezza degli allegati informativi sul prodotto, in conformità con la legislazione del paese di riferimento;
Partecipazione a conference call e meeting in inglese in team multi e cross-funzionali.

Requisiti:

Breve esperienza (6/12 mesi) nelle procedure centralizzate
Ottima conoscenza della lingua inglese scritta e parlata valutata in sede di colloquio;
L’approccio consulenziale e collaborativo con i colleghi e le colleghe e con i clienti;
Spiccate qualità di team player, per favorire confronti costruttivi e la condivisione di informazioni sia con i collaboratori interni che con i clienti o fornitori coinvolti nei progetti;
Un’ottima capacità di gestire lo stress, mantenendo il controllo e il focus sulle priorità;
Orientamento al problem solving e determinazione nel conseguimento degli obiettivi assegnati;
Una buona gestione del tempo (rispetto delle scadenze, definizione di priorità ed urgenze);
Orientamento alla qualità;
Adattabilità al cambiamento.

Si offre: sistema di welfare, previdenza complementare aziendale, benefit, formazione continua, eventi.

Presenta il tuo cv alla nostra mail selezione@s4btsrl.com

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Engineering & Business Support - Talent Pipeline for Internships

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Employer: Novo Nordisk
Location: Bagsværd, Denmark
Role: General Management and Administration
Contract: Internships (remunerated if your educational track allows this) - from 3 to 6 months (to a maximum of 12 months) - Full time
Working hours: between 18-37 per week

To drive change, Novo Nordisk is pioneering the use of modern technologies to improve the process and increase efficiency across our pharmaceutical manufacturing sites. And you can be a part of this journey. Are you looking for an internship where you can explore how to use your theoretical knowledge in everyday business life? Then apply to our Engineering and Business Support Talent Pipeline.

Internships within Engineering and Business Support
We offer internships within these areas in many different departments of our business but most of our internships are on our pharmaceutical manufacturing sites.
You will be a fully-fledged member of the team from day one, and we count on you to present your ideas. In return, we promise that you will get the chance to play an instrumental role in the development and scaling of the technology across the production at our manufacturing hub.

You will be supporting and exploring ways to utilise capabilities within e.g.:

Data access and architecture
Advanced automation
Machine vision
Machine learning
Mechanical design and simulation
Virtual or augmented reality

Your tasks will vary from department to department but could cover:

Supporting projects around improvements in our manufacturing setup
Support in cross-functional activities advancing the use of innovative novel and existing technology
Support in projects around the design, development, and maintenance of operations information systems to monitor manufacturing efficiency.

The Engineering and Business Support Talent Pipeline covers internships in the following fields:

Data engineering and software engineering
Production and test of production lines
Automation disciplines, e.g. robotics
Mechanical development and solutions
Modelling (pilots, testing, etc.)
Innovation- and process optimization
Business Support

Qualifications:

currently enrolled in a Bachelor’s or Master’s degree in Engineering e.g. Mechanical, Chemical, Production, Innovation or another relevant field
you have at least 6 months left of your studies
you are keen to learn and able to manage your own time
t’s an advance if you are a bit experienced with working in your field and used to working with a various number of stakeholders
Fluent in English > you need to submit your CV in English.

Internship details:
Working hours for internships in Novo Nordisk is between 18-37 per week, but most internships are 37 hours per week with a small possibility to work from home – most of the work will be on-site. For Novo Nordisk, you as a student must get the flexibility that allows you to prioritise your exams and assignments as needed.

A Danish full-time work permit is required.

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Joining a Talent Pipeline in Novo Nordisk
Most of our internships a filled through our Talent Pipelines which means that by joining the pipelines you will get the opportunity to get matched with a lot of internships that never get posted.
When applying to this Talent Pipeline you will be considered as a potential match for several internships within the fields of Engineering and Business Support, and if there is a match, we will reach out to you and invite you for a 1st interview with the hiring manager.

You will only be contacted if we find a relevant position that matches your profile, but you will remain part of the Pipeline for up to 6 months unless you inform us that you wish to withdraw.

Due to GDPR, we are closing the pipelines after 6 months and we send email notifications to all active candidates in our pipelines when they are closed, - with a link to where you can re-apply to our new line of Talent Pipelines.

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QA master data - Latina

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Sede: Latina
Modalità: on site
Tipologia di Contratto: somministrazione di 12 mesi, inquadramento e livello da definire sulla base della reale esperienza del candidato.

Mansioni:

Contribuisce al flusso di approvazione della documentazione di produzione (Master Batch Record) e di laboratorio, e dell’anagrafica dei materiali, degli equipment e delle risorse (Master Data), assicurando il rispetto dei tempi e la qualità dell’intero processo, controllando e garantendo la gestione dei dati critici;
Svolge attività di supporto nei processi di qualità, inclusa la gestione di incidenti di qualità, il monitoraggio dell’implementazione di azioni correttive e preventive (CAPA) e richieste di cambiamento (Change Control) legate ai progetti assegnati;
Collabora e partecipa come riferimento Quality per il sito ai team crossfunzionali di progetto (NPI, Technology Transfer, Technical Launch, Validation Process) al fine di assicurare le date di lancio dei prodotti sul mercato;
Gestisce la risoluzione delle problematiche dei diversi reparti dello stabilimento in relazione alla gestione dei prodotti, dei processi, di equipment/facilities/utilities al fine di assicurare la qualità, sicurezza ed efficacia dei prodotti.

Completano il profilo:

pregressa esperienza in ruoli analoghi,
buona padronanza di excel e nell’utilizzo di SAP,
buona conoscenza dell’inglese tecnico,
curiosità e capacità di lavorare per obiettivi.

Titolo di Studio: Laurea in discipline scientifiche.

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Technical Operations Intern - Latina

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Sede: Latina (LT)
Orario: Full Time con disponibilità a lavorare su turni (mattina/pomeriggio/notte)
Disponibilità: immediata
Tipologia di contratto: iniziale stage extracurriculare trimestrale, finalizzato ad assunzione in apprendistato. Si offre: sistema di welfare, previdenza complementare aziendale, benefit, formazione continua, eventi.

S4BT è un’Azienda di oltre 80 specialisti, che da oltre 25 anni fornisce soluzioni software e consulenze per il settore Life Science e non solo in ambito Qualità, Ingegneria, Project Management, Validazioni, Tech Transfer, CSV e altro.
A supporto del team della Business Unit Technical Operations, cerchiamo un profilo neolaureato che, grazie al supporto di un tutor, intraprenderà un percorso formativo tale da ricoprire il ruolo di Technical Operations Intern.

Attività:
• Avrai l’opportunità di intraprendere un percorso formativo che ti permetterà di eseguire attività di progetto in ambito Tech Operations (redazione di documenti, attività in turno e campionamenti su processi di manifattura farmaceutica e cleaning) in termini di:

partecipazione a corsi di formazioni erogati all’interno dell’azienda;
affiancamento nei progetti assegnati;

• Parteciperai a meeting di condivisione di progetto e di area con tutto il team Technical Operations.

Cosa ci piace in un/a candidato/a:

l’approccio da vero/a team player, capace di favorire confronti costruttivi, condividere informazioni e fornire feedback sul proprio lavoro;
la curiosità, l’entusiasmo e l’energia;
la ricezione di fronte alle linee guida aziendali;
la partecipazione e la proattività verso iniziative legate a progetti interni all’azienda.

Requisiti:

laurea magistrale in discipline tecnico-ingegneristiche e chimico-farmaceutiche;
interesse e curiosità nelle convalide di processo e cleaning di manifattura in ambito farmaceutico;
buona conoscenza della lingua Inglese sia scritta che parlata (livello minimo B1);
buona conoscenza del pacchetto Office.

Presenta il tuo cv alla nostra mail selezione@s4btsrl.com

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Informatore Medico Scientifico In P.Iva – Firenze

Laboratory Technician for Quality Control - Microbiology Lab Department

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Employer: AGC Biologics
Location: Copenhagen, Denmark

Are you looking for new challenges in an international and inspiring environment?

Tasks and Responsibilities:

Endotoxin and microbiological analysis on APIs.
You will assist in administrative tasks e.g. review and approval of analytical results.
You will have the opportunity to do investigations/support and follow-up on corrective/preventive actions in co-operation with Development and Manufacturing departments.

Your Profile:

We expect you to hold a degree as laboratory technician or similar and preferably have some experience within the pharmaceutical industry. In addition, we expect you to bring some of the following experiences and characteristics:

Experience with pharmaceutical microbiological analyses
Knowledge within endotoxin analysis on water and API
Potential experience with LIMS
Experience working with cGMP
Have a high Quality mindset
Experience with data review
A flexible, dynamic and excellent team player with good English and Danish skills
A good sense of humor and the ability to plan and complete your work independently and efficiently
Taking responsibility for your personal assignments and completing high quality work in a timely manner.

The Department:

The Quality Control unit at AGC Biologics A/S consists of; QC Bioassay, QC Chemistry, QC Microbiology, QC Support and QC Equipment and Planning. QC Microbiology consists of two teams; Environmental Monitoring and Microbiology Laboratory. QC Microbiology Laboratory (consisting of 6 highly dedicated technicians and 7 scientists) is responsible for microbiological analysis on APIs for clinical and commercial samples, method validation, microbiological analyses on pharmaceutical water, and Endotoxin analysis on APIs. The work is conducted under cGMP and AGC Biologics handles exciting customer projects from phase I to commercial stages. The department works in collaboration with Manufacturing, QA, Up-and Downstream Development, Analytical Development and external laboratories to maintain control of all steps in the manufacturing processes. Everything we do, we do in collaboration with our customers.

---

About the Company
AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services. Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.

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Addetto Ufficio Regolatorio - Lodi

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Sede: Lodi
Moadalità: on site
Tipologia di Contratto: si offre assunzione diretta a tempo indeterminato e livello e retribuzione commisurate all'esperienza.

Mansioni:

Gestione e preparazione della documentazione per la registrazione di Dispositivi Medici a livello Internazionale (APAC, EMEA e LATAM);
Collaborazione con altre Funzioni (R&D, Medical Affairs, QA, QC e Vigilanza) per ottemperare a Richieste da parte di Autorità Competenti durante procedure di registrazione;
Supporto Quality Assurance durante gli Audit da parte delle Autorità Competenti;
Mantenimento e aggiornamento delle registrazioni nei database.

Completa il profilo:

La pregressa esperienza in ruolo e settore analogo di almeno 6 mesi,
buona conoscenza della lingua inglese,
capacità di lavorare in team e di interagire trasversalmente con altri reparti coinvolti.

Titolo di Studio: Laurea in discipline scientifiche quali Farmacia, Chimica e Tecnologie Farmaceutiche

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Analista Di Laboratorio Chimico - Paderno Dugnano (MI)

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Sede di lavoro: Paderno Dugnano (MI)
Si offre: contratto di somministrazione a tempo determinato

Descrizione ruolo:
La risorsa inserita si occuperà del controllo e prelievo dei prodotti finiti, materie prime e intermedi in accordo al SGQ e nello specifico si seguirà le seguenti attività:

Eseguire tutti i test chimici, necessari alla produzione di farmaci, dispositivi medici e cosmetici in qualità, sicuri ed efficacy;
Verificare l’efficienza e la calibrazione delle apparecchiature analitiche;
Registrare i risultati delle analisi effettuate sugli appositi moduli cartacei ed informatici;
Utilizzare strumentazione, aree e locali ed eseguire tutte le attività a proprio carico, rispettando quanto prescritto da procedure e istruzioni operative interne;
Segnalare immediatamente al Responsabile Controllo Qualità qualunque non conformità, deviazione, trend anomalo verificati durante lo svolgimento delle proprie attività.

Requisiti richiesti:

Diploma o Laurea in ambito scientifico preferibilmente in Biologia, Biotecnologia o Chimica e Tecnologie Farmaceutiche;
Preferibile esperienza pregressa nel ruolo.

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Graduate programms - differente faculties

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Employer: Novo Nordisk
Location: Gladsaxe(Denmark)
Contract: Temporary position - Full-time
Start working 1^st September 2024

Turn your master’s degree into a global career

Building on our 100-year legacy as a world leader in diabetes care, we are expanding our commitment into several therapy areas, including obesity and cardiovascular disease. We are on a relentless mission to drive change for millions of people living with chronic diseases. We need people like you to join us on this mission and take Novo Nordisk into the future.

Programme description:
Our global Graduate Programme is designed to bring together change makers with a diversity of perspectives and equip them with the tools needed to accelerate their personal and professional development. The two-year programme allows you to explore the world while developing your career. You will be taken on three to four rotations around the globe where you will work in a fast-paced environment and grow in ways you never could have imagined. You will be exposed to the entire Novo Nordisk value chain while being challenged to explore your boundaries and reach your full potential.

After successfully completing the programme, you will have the necessary professional and personal skills to embark on your global career with the guarantee of a position at Novo Nordisk.

Which Field?

Technology:
We have 3 different tracks within Technology:

Global Digital Business
Data Science
Manufacturing Technology

Pharmaceutical Development Graduate Programmes:
This 2-year graduate programme will give you comprehensive knowledge of the key departments in the drug development value chain from the early clinical trials phase to the regulatory approval process as well as drug safety surveillance.

Regulatory, Medical and Safety
Trial Management

Business, Commercial Marketing & HR:

Global Business
Global Commercial Marketing
International Operations Business
International Operations HR
US HR
US Business

Finance Graduate Programmes:

International Operations Finance
Global Finance

Procurement & Supply Chain Graduate Programmes:

Global Procurement
Global Supply Chain

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Junior Quality Assurance Officer

Medici di Guardia - varie sedi Italia

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Requisiti:
• Laurea in Medicina e Chirurgia e Iscrizione all’Ordine dei Medici
• Disponibilità a turni notturni/festivi (da concordare con la struttura)
La ricerca è rivolta a entrambi i sessi (Legge 903/77 e art.8 D.lgs 196/00).

Tipologia contrattuale:
• Stipula di contratto libero professionale con P.IVA
• Compenso in linea con i valori della Sanità Pubblica
• Piattaforma scontistica riservata ai dipendenti/collaboratori KOS
• Percorsi di formazione aziendale attraverso la nostra Kos Academy

Sedi di lavoro:

TRENTINO ALTO ADIGE
• Santo Stefano Riabilitazione Ospedale San Pancrazio ad Arco di Trento (TN)

LOMBARDIA
• Residenze Anni Azzurri site a Milano e hinterland
• Santo Stefano Riabilitazione Villa San Giuseppe ad Anzano del Parco (CO)
• Santo Stefano Riabilitazione a Casorate Primo (PV)
• Santo Stefano Riabilitazione a Mede (PV)

EMILIA ROMAGNA
• Santo Stefano Riabilitazione Centro Cardinal Ferrari a Fontanellato (PR)

TOSCANA
• Clinica Specialistica Psichiatrica Ville di Nozzano a Nozzano San Pietro (LU)

MARCHE
• Santo Stefano Riabilitazione a Cagli (PU)

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Business Developer Healthcare – Roma

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Adecco, divisione specializzata Lifescience, per conto di nota realtà internazionale operante nel settore Healthcare ricerca un/a: BUSINESS DEVELOPER

Tipologia di contratto: diretta a tempo indeterminato - full time (38/40 ore)
Inquadramento contrattuale: CCNL UNEBA, Livello da 3S a 2 a seconda dell'esperienza
RAL: 26-28K + 5K di bonus + auto ad uso promiscuo.

Le attività che la risorsa dovrà svolgere sono:

sviluppare il portafoglio clienti;
individuare e comprendere i bisogni latenti dei clienti già acquisiti e mantenere la relazione commerciale;
promuovere il servizio ADI (Assistenza Domiciliare Integrata);
sviluppo specifici progetti Value Based Healthcare.

Requisiti necessari:

professionista con titolo di studio in ambito sanitario/medicale
FONDAMENTALE esperienza in ruolo commerciale in ambito sanitario/medicale
profilo dinamico, con spiccate attitudini comunicative e motivazione all'assunzione di un ruolo commerciale;

Link all’annuncio Adecco: https://go0.it/1ZX6P

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Regulatory Affairs stageur

QA Associate

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Location:

As a part of the Quality Assurance department of the API - Plant (Active Pharmaceutical Ingredient) we are hiring a Quality Assurance Associate.

Your key tasks and responsibilities:

Drafting and implementation of policies and procedures for compliance with Italian regulations;
Management of OOS and related CAPA;
Management of changes;
Revision of production documentation;
Management of audits (internal and suppliers);
Training for internal staff;
Any activity aimed in compliance with current GMP.

Requirements:

Master of Science (Chemistry, CTF, Pharmacy, Industrial Chemistry);
1-3 years experience in GMP chemical-pharmaceutical or API companies;
Knowledge of pharmaceutical regulations and guidelines;
Excellent knowledge/use of software (MS Word, MS Excel);
Good Knowledge of Data Integrity issues;
Good team working skills;
Excellent knowledge of English.

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Quality System Manager

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Location: Pomezia (RM)
Expected Travel: 0-10 %

Context:
The candidate will be introduced within the Quality Assurance Department and will report directly to Head of QA. The Quality System Manager leads a team of Quality System Specialists managing the daily support to Site compliance and governance.

Responsible for Quality System oversight in order to assure compliance to GMP requirements. Proactively leads quality system enhancement projects assigned. Immediately reports any non compliance to his direct superior. Works in close collaboration with Quality Control, Production, Warehouse, Validation, Engineering and Maintenance and effectively supports other functional areas to solve issues and to provide guidance in case of compliance issues and/or new site/corporate policy requirements. Responsible for the development and management of direct reports and supervision of of activities improving the Quality system and supporting other departments.

Main activities and responsabilities:

Responsible for Quality System of MBH Pomezia. Site owner of quality systems streams as Deviation, CAPA, Change control, Documentation, Training, Supplier Qualification.
Lead daily activities of Quality System personnel, supporting Warehouse, Manufacturing, QC, Engineering and Maintenance. Assure job objectives are met on a timely basis.
Oversee the training of all personnel being on site. Effectively develop, manage and motivate staff. Write and administer performance for department personnel.
Review and approve SOPs and assure SOPs define the steps necessary to complete tasks.
Ensure that the Quality System team provides adequate and timely quality compliance support for all GMP areas such as Warehouse, Production, Engineering and Quality Control.
Ensure Change control is appropriately managed, implemented and changes are closed within a predefined time frame.
Ensure Self-Inspections are appropriately performed and CAPA are implemented within the defined timeframe.
Ensure that the defined training program of all staff is appropriately performed and documented.
Ensure Supplier Qualification is appropriately managed.
Ensure efficience of deviations and investigations system. Ensure CAPA is appropriately determined and implemented and carried out within the defined timeframe.
Support the site management review/periodic trending program e.g., compile data and complete analysis, prepare summary and provide required information to Head of QA.
Develop and lead an internal assessment program and support corporate or external audits and inspections.
Maintain and implement knowledge of current GMPs and regulatory guidelines.
Proactively provide and evaluate new information to assure current status with compliance and regulatory issues through evaluation of available documentation.
Participate actively in the preparation and execution of internal and external audit and regulatory authorities inspection.
Ensure the management of the risk related to overall activities of the site. Conduct risk assessment of processes when requested.
Any other additional tasks requested by Head of QA in order to provide support to QA organization.

Job requirements:
Education

Bachelor’s degree Pharmacy, Chemistry, Biology, Biotehchnology or related field.

Years of experience

At minimum 6 (six) years of quality system /quality assurance experience with in the regulated pharmaceutical industry

Qualification and skills

He/she should be highly organized and detail-oriented.
He/she should demonstrate effective time management.
The candidate should have the ability to communicate and collaborate effectively within team and with members of other departments.
He/she should have the ability to work well with others in fast paced, dynamic environment.
He/she should be respectful, approachable and team oriented while building strong working relationships and a positive work environment.

Language skills and level of proficiency

English-Intermediate Level

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Medical Science Liaison (MSL) in BMS

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Ruolo: Medical Science Liaison (MSL)
Disponibilità a viaggiare: fino al 70%
Sedi varie: si richiede residenza e/o domicilio nelle zone NORD Italia, CENTRO Italia oppure SUD Italia.

Hai voglia di nuovo sfide? Vuoi continuamente imparare e migliorarti? Ti piace un lavoro dinamico e credi nel gioco di squadra? Se hai risposto sì a queste 3 domande continua a leggere perché questo è il lavoro che fa per te.

Descrizione:
In qualità di Medical Science Liaison (MSL) svolgerai un ruolo fondamentale nel trasferire le nostre conoscenze scientifiche per avere un impatto positivo sul cambiamento della vita dei pazienti.

Sarai il primo punto di contatto per qualsiasi aspetto o problema medico/scientifico relativo ai prodotti a te assegnati, impegnandoti nello Scambio Scientifico sia con i team di Bristol Myers Squibb, sia con i principali esperti esterni, gli operatori sanitari e gli sperimentatori clinici.

Ti confronterai con esperti a livello nazionale ed internazionale per aumentare l’attenzione sulla malattia e sulle opzioni terapeutiche, per identificare bisogni clinici insoddisfatti, lacune nelle evidenze scientifiche e per ottenere insights.

Compiti e responsabilità:
In qualità di Medical Science Liaison (MSL) sarai responsabile di:

Fungere da punto di contatto all'interno del team Medical Affairs per gli Opinion leaders e gli esperti nella tua area geografica al fine di soddisfare le loro esigenze di approfondimento scientifico nell'area terapeutica e per i prodotti assegnati, garantendone l'uso sicuro, efficace e appropriato.
Assicurare la leadership scientifica costruendo relazioni professionali con gli Opinion leaders e gli esperti delle aree terapeutiche.
Garantire una forte presenza medico-scientifica nei principali centri accademici, facilitando le iniziative di ricerca e di formazione e supportando le richieste di approfondimento scientifico sulle aree terapeutiche assegnate.
Assistere nell'avvio, supervisione e follow-up degli studi clinici e dei progetti medici avviati nell'ambito dell'area terapeutica e del territorio assegnato.
Fungere da punto di contatto con gli Opinion leaders per facilitare la condivisione di idee di ricerca clinica o pre-clinica e la sottomissione di richieste di supporto per la ricerca sponsorizzata dagli sperimentatori (Investigator Sponsored Research, ISR) al team medica locale e/o a quello Worldwide, a seconda dei casi.
Interagire con gli Opinion leaders che l'azienda desidera coinvolgere in attività come potenziali collaborazioni di ricerca, ruoli educazionali o di consulenza (Advisory Boards, Congressi, Simposi, ecc.), garantendo al contempo un elevato livello di integrità scientifica ed educazionale.
Partecipare a congressi scientifici di rilievo. Collaborare con gli stakeholder interni per sviluppare una reportistica tempestiva sui dati chiave e altre informazioni scientificamente rilevanti per informare le iniziative strategiche di BMS.

Altre attività:

Fornire supporto scientifico alla preparazione della Field Force per garantire standard di alta qualità nello svolgimento delle loro attività.
Supportare i medici responsabili di prodotto e il dipartimento di Farmacovigilanza nella gestione degli eventi avversi (ad es. raccolta di informazioni di follow-up).
Supporto al team WW per le attività assegnate.

Requisiti essenziali:

Laurea in Medicina e Chirurgia
Buone capacità di comunicazione scritta e orale
Buona comprensione dell'inglese scritto e orale
Ottime capacità sociali
Adeguate competenze informatiche (Office, Outlook, Web, ecc.)
Inclinazione al lavoro di squadra
Capacità di lavorare in modo indipendente e di assegnare priorità alle diverse attività
Patente di guida

Requisiti auspicabili:

Doti di presentazione di dati scientifici
Conoscenza dell'area terapeutica Immunologia
Esperienza nella preparazione ed esecuzione del lancio di un prodotto
Conoscenza dei requisiti normativi locali relativi alle attività del Medical Affairs

L’appartenenza alle categorie protette, lg. 68/99 costituirà titolo preferenziale.

_ _ _ _

Ti sei riconosciuto nei requisiti?

Candidati oggi stesso!

Al termine dell'evento online del Bio Pharma Day i tuoi dati e cv verranno inviati al team di reclutamento che valuterà il tuo profilo (qualifiche, competenze ed esperienza) ed esaminerà il tuo CV per determinare se le tue competenze ed esperienze corrispondono al profilo professionale. I candidati selezionati, che corrispondono al profilo, saranno contattati per un colloquio.

What’s important to us? Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:

Passion: Our dedication to learning and excellence helps us to deliver exceptional results.
Innovation: We pursue disruptive and bold solutions for patients.
Urgency: We move together with speed and quality because patients are waiting.
Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments.
Integrity: We demonstrate ethics, integrity, and quality in everything we do for patients, customers, and colleagues.
Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential.

We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve.

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BMS Specialist for large-scale pharma projects

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Employer: Ramboll
Location: Copenhagen, Denmark
Role: Building Management Systems
Contract: Full-time

Job description:
Join us for the chance to work on large-scale pharma projects with international clients and colleagues! We are looking for an experienced BMS Specialist to design and provide consultancy on BMS solutions towards clients that are at the forefront of the green transition. Together with 18,000 colleagues globally, we invite you to close the gap to a sustainable future as you create innovative solutions that will shape the future of the pharma industry. Are you our new colleague?

You will join Ramboll’s Pharma and Life Science division:
As our new BMS Specialist, you will join our department for Electrical, BMS and Automation, which sits in our Pharma and Life Science division. We are currently more than 100 people, working on complex pharma projects in Denmark. We have the competencies to provide our clients with end-to-end consultancy throughout all the phases of the project – including architectural design, structural engineering, HVAC solutions, process engineering and project management. We support our clients on new constructions as well as renovation of existing production facilities (including filling lines and API manufacturing plants), laboratories as well as clean rooms, which involve requirements in terms of GMP, GLP, SIL.

You will work closely together with colleagues in your team, but also continuously liaise with rest of the pharma organisation. Joining a global organisation, you will also get access to a vast network of expertise spanning geographical boarders. We believe in sharing knowledge and exchanging competencies to ensure that we bring the best of Ramboll in all projects.

Your key tasks and responsibilities:

Qualified consultancy and sparring to clients and internal project managers
Design of BMS and FMS solution including a focus on energy optimisation and sustainability
Defining the strategy and aligning on the project plan together with clients and colleagues in other disciplines
Coordinating deliverables with other disciplines on projects
Follow-up and supervision of projects
Participating in commissioning and system optimisation

Your starting point for continued growth:
To thrive and succeed in this role, we expect you to have experience with BMS and an in-depth understanding of the pharma industry. More specifically we expect the below to resonate with you:

Min. 3 years of experience with the design of BMS solutions on pharma projects
Experience navigating the complexity of multidisciplinary projects
An interest in sustainability and developing sustainable solutions
Solid communication skills in English – written and spoken

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The Company
At Ramboll, we are committed to creating a sustainable future for generations to come. With our strategy, The Partner for Sustainable Change, we go all in on sustainability, employing the expertise we have built up over decades to drive the change that is needed to realise a future with better living conditions for people and nature. There is a gap in the world between where we are today and a sustainable future. We invite our clients, partners, and future colleagues to work with us to close that gap.

As one of the top 10 building designers in the world, Ramboll works on more than 10,000 building projects each year. 5,000 experts across the world specialise in creating more innovative, sustainable and liveable buildings. We place particular emphasis on our liveable buildings concept where we balance the cultural, social and physical values of buildings, to improve the quality of life for building users.

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Tecnico di Fisiopatologia Respiratoria - Lombardia

Addetto/a Controllo Packaging - Cuneo

QA on the floor specialist

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Sede: Monza
Modalità: Full-time in presenza, con turni
Tipologia di contratto: determinato o indeterminato diretto con azienda

Descrizione ruolo:
In base alle indicazioni del Quality on the Floor Team Leader, del Quality Operation Supervisor e del Quality Operations Manager, la risorsa si occupa della Batch Record Review dei lotti GMP nel rispetto delle procedure aziendali, degli standard di qualità e delle normative vigenti (leggi, norme GMP, FDA, etc.) e della sorveglianza delle attività produttive, diffondendo pro-attivamente la Quality Culture all’interno dei Reparti.

Mansioni:

Effettua la revisione dei lotti GMP rilevanti e ne verifica la conformità alle specifiche, alle procedure aziendali ed alle normative vigenti dichiarandola mediante l’utilizzo dell’apposita check-list.
Effettua sorveglianze periodiche delle attività produttive e promuove la Quality Culture diffondendola pro-attivamente all’interno dei Reparti.
Incoraggia la condivisione delle problematiche e delle relative azioni correttive con il Reparto Produzione mediante huddle periodici.
Partecipa, in collaborazione con il Reparto Produzione e il Team PPI, al miglioramento continuo del Reparto, fornendo supporto nell’implementazione di nuovi flussi, nell’ottimizzazione di procedure o nella creazione di Tool PPI.
Esegue l’addestramento del personale coinvolto nella attività di Quality on the Floor e di quello operante nei Reparti per attività legate alla propria area di competenza, in accordo alle vigenti procedure aziendali.
Collabora con la funzione Quality Operations e con i Quality Specialist di Reparto al fine di assicurare la corretta esecuzione delle indagini, fornendo supporto per la comprensione delle cause e partecipando all’identificazione delle più idonee azioni correttive o preventive, in accordo agli standard qualitativi aziendali ed alle normative vigenti.
Opera nel rispetto degli standard di qualità aziendali, attraverso l’applicazione delle procedure relative alla propria area di competenza, nel rispetto delle politiche e delle procedure di qualità aziendali ed in accordo alle normative vigenti (leggi, norme GMP, FDA, etc.).

Requisiti:

Laurea in CTF, Farmacia, Chimica, Biologia, analoghe lauree a indirizzo scientifico.
Almeno 2 anni di esperienza in realtà farmaceutiche in ruoli all'interno dei Reparti QA o Produzione.
Disponibilità a lavorare su turni (7x3, ciclo continuo)
Buona conoscenza della lingua inglese.
Capacità di lavorare in team ed ottime doti relazionali.

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