Array ( [id] => 1131 [azienda_id] => 212 [lauree] => {59}{68} [settore] => [ruolo] => [inserimento] => [time_c] => 0 [last_mod] => 1700655507 [title] => QC Chemistry Analyst [body] =>

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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Array ( [id] => 1130 [azienda_id] => 212 [lauree] => {null} [settore] => [ruolo] => [inserimento] => [time_c] => 0 [last_mod] => 1700655432 [title] => QA-RA Compliance Officer [body] =>

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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Array ( [id] => 1125 [azienda_id] => 212 [lauree] => {null} [settore] => [ruolo] => [inserimento] => [time_c] => 0 [last_mod] => 1700655380 [title] => Senior EU QA Officer [body] =>

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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Array ( [id] => 1124 [azienda_id] => 212 [lauree] => {null} [settore] => [ruolo] => [inserimento] => [time_c] => 0 [last_mod] => 1700655412 [title] => EU QA Officer [body] =>

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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