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Employer: Thermo Fisher Scientific
Position: Stage area Quality Assurance 
Duration: 6 mesi - Full Time
Work place location: Monza - team Quality Assurance

Le risorse, inserite all'interno del team di Quality Assurance, durante il loro percorso avranno modo di lavorare all’interno dei vari team di Quality Assurance contribuendo a migliorare la capacità di analisi e di monitoraggio in un contesto nuovo e in continua evoluzione.

Apprenderanno da vicino quelle che sono le procedure che governano il settore della produzione farmaceutica:

• Daranno supporto nella gestione e aggiornamento batch record;
• Supporteranno nella parte di investigation, oltre che nell'organizzazione dei training previsti ai fini GMP;
• Avranno altresì modo di seguire i processi di convalida e ispezioni interne (preparazione e organizzazione di documenti, check list di processo);
• Potranno eseguire oversight periodici nei vari reparti produttivi. 

Si richiede:

• Laurea in Chimica e Tecnologie Farmaceutiche o affini
• Ottima conoscenza pacchetto office
• Buona conoscenza della lingua inglese, scritta e parlata.

Si offre:

• Stage di 6 mesi retribuito
• Mensa aziendale

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Employer: Thermo Fisher Scientific
Position: Quality & Regulatory - Full Time
Work place location: Monza - Pharmaceutical Development department

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $35 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

Monza offers compliance with controlled drug regulations in Europe and the U.S. as well as disposable manufacturing technologies and fully integrated secondary packaging services, and has received regulatory approval from various international regulatory inspection agencies, including: ANVISA, JP PMDA, US FDA, EMA, GCC States, Canada, Russia, Taiwan, Turkey. The Monza site currently supplies over 20 countries – all the major international markets, including the U.S., Europe and Asia Pacific.

The candidate will join the Analytical Development team in newly-built Pharmaceutical Development department and will perform required analysis to ensure that clients’ requests are met according to SOP, GMP and GLP.

Depending on the indications received from the Team Leader, he carries out the tasks and activities listed below for which he has been enabled by the appropriate training, in compliance with company and departmental SOPs and current safety regulations.

• Manage all the reagents and analytical reference standard used by QC PDS laboratory in agreement with the GMP, Data Integrity and SOPs. He is responsible for all the documentation (CoA, MSDS, labels etc… 
• He is also collaborate for the correct storage of standard and reagents;
• He contacts with suppliers (Clients or pharmacopoeia) in order to receive information about the analytical reference standard and reagents;
• He supports and collaborate with analysts, scientist and Team Leader in the use of reagents and reference standard for each PDS projects;
• He supports Team Leader during Client’s and Regulatory Audit for the standard and reagents management (in terms of SOPs, documentation and storage);
• He is responsible for the sampling procedure in order to organize sample shipment to Clients, external Laboratory;
• He collaborates with Team Leader for the organization of sample stability shipment and labeling for all the samples dedicated to stability studies according to the SOPs;
• It deals with the preparation of reagents and standard substances, as well as the relative controls according to the provisions of the SOP / methods in use;
• He takes care of keeping the materials in good condition for their use in the analytical field, guaranteeing their conservation under the conditions indicated in the corresponding documentation;
• Takes care of the drafting and compilation of laboratory documentation (eg notebooks, registers, etc.);
• Takes care of the tools, materials and work environment, promptly communicating any anomalies to the Team Leader;
• In compliance with company procedures, it takes care of collecting waste and laboratory waste appropriately. 

Requirements:

• High school degree
• Office program
• Knowledge of company procedures and GMPs, Sops and Data integrity
• Knowledge of notions and laboratory computer programs
• Professional experience pharmaceutical companies

 

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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Employer: Thermo Fisher Scientific
Position: Quality & Regulatory - Full Time
Work place location: Monza -  PDS Analytical Development&GMP Department

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $35 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

Monza offers compliance with controlled drug regulations in Europe and the U.S. as well as disposable manufacturing technologies and fully integrated secondary packaging services, and has received regulatory approval from various international regulatory inspection agencies, including: ANVISA, JP PMDA, US FDA, EMA, GCC States, Canada, Russia, Taiwan, Turkey. The Monza site currently supplies over 20 countries – all the major international markets, including the U.S., Europe and Asia Pacific.

The candidate will join the PDS Analytical Development&GMP Department in a new built of Pharmaceutical Department (PDS) as QC LIMS Technician.

As QC LIMS technician you will join the QC Data Integrity & LIMS team, acting as a key user of the LIMS system, in support to QC laboratories and other Quality functions. Your main duties will be, but not only:

• Management (creation/update/decommissioning) of static data on the system: materials, specifications, lot plans and operations.
• Changes and deviations impact evaluation and relevant action plans implementation on the system.
• System Audit Trail check in course of lot release.
• SME support to users.
• LIMS- related Data Integrity issues addressing.

In addition, you will be involved, when needed, in readiness activities for the deployment of the new Global LIMS system (Sample Manager) incoming in the near future, such as:

• Sample workflow mapping
• Issue of dedicated procedures and work instructions
• Initial data loading
• Users training

Technical skills:

• At least 2 years of experience in Pharmaceutical/Biomedical context.
• Previous experience with a LIMS system.
• GMP & Compliance knowledge.
• Good English level (written and spoken).
• Basic IT knowledge of SQL databases is a plus.

Soft skills:

• Precision and attention to details.
• Attitude to teamwork and self-organization.
• Interpersonal and good communication skills.

At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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Employer: Thermo Fisher Scientific
Position: Quality & Regulatory - Full Time
Work place location: Monza -  PDS Analytical Development&GMP Department

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $35 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

Monza offers compliance with controlled drug regulations in Europe and the U.S. as well as disposable manufacturing technologies and fully integrated secondary packaging services, and has received regulatory approval from various international regulatory inspection agencies, including: ANVISA, JP PMDA, US FDA, EMA, GCC States, Canada, Russia, Taiwan, Turkey. The Monza site currently supplies over 20 countries – all the major international markets, including the U.S., Europe and Asia Pacific.

The candidate will join the PDS Analytical Development&GMP Department in a new built of Pharmaceutical Department (PDS). You will:

• Reporting to the PDS AD&GMP Supervisor, they are responsible for the assigned projects, responsible for all the documentation related to QC PDS Laboratory in such a way as to ensure the successful continuation of the projects within the PDS.
• Collaborate with all the functions within the company in the implementation of analytical requirments respecting the company quality standards.
• Collaborate for the analytical documentation of APIs, Excipients and DP (release and stability tests), preparing the analytical method and supporting the upload of these on the computerized systems.
• Collaborate with Clients, QC PDS, Regulatory Department, QC Compliance, QA and QO in order to issue the correct documents for PDS projects, respecting the ICH and Pharmacopoeia.

You will a part, supported by the QC Documentation Team, of discussion about compliance consulting and strategic advice to internal and external clients to determine the most appropriate approach in order to have compliant documentation for their products.

Will be a part, supported by the QC Documentation Team, to project specific strategy, technical expertise in QC Documentation matter and collaboration oversight for key client’s projects. With the QC Documentation team will be an executive contact for key clients for all issues, including attendance at regulatory authority meetings and other public relation functions. Ensures quality performance for key/managed projects.

In this role will be part of a cohesive team responsible for Deviations, CAPAs, and Change Controls for all phases of PDS Projects. You will:

• Improve of analytical skills cGMP regulations to ensure full Quality compliance.
• Works supporting the QC PDS Documentation Team performing work that consistently support Client’s expectation and respect of Client’s timelines.
• Collaborate with the Team to plans for future customer activities and solicit other projects that are aligned with the company goals & objectives.
• Contribute to updating the procedures relating to the area of competence, by drafting and reviewing them as needed, in compliance with current regulations, laws and GMP standards.
• Contribute the continuous updating of the procedures concerning the area of competence in the drafting and updating of the same, in compliance with current regulations (current EU GMP, US GMP)
• Support the Qc Documentation team to perform laboratory investigations, laboratory OOS and OOT and any deviations and CAPA related to the PDS Projects.
• Collaborate for the evaluation of OOS, OOT and laboratory investigation in terms of recurrences, root cause, trend and define CAPAs.

Relationships:

Interiors

• Production departments
• QA
• Regulatory
• Logistics
• TT / Business

Exterior

• Clients
• External laboratories

Requirements and qualifications:

• ESSENTIALS: Bachelor's degree in chemical engineering, chemistry, or equivalent degree.
• Technical and IT knowledge: GMP standards applied to Quality Control laboratories, with particular reference to stability studies.
• Knowledge of laboratory concepts and computer programs: Knowledge of data management and evaluation systems.
• Professional experiences: In the laboratory of analysis at university or pharma companies.
• Languages: English

Personality traits:

• Flexibility and adaptability.
• Good organization and planning skills
• Excellent listening, oral, and written communication skills
• Ability to work in a team

At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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