Azienda

Alti Profili

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Indirizzo

Latina, Lazio

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For our client, one of the leading contract manufacturers of pharmaceuticals, medical devices, dietary supplements, and cosmetics, we are hiring

PRODUCT ASSURANCE MANAGER

 Position Duties and Responsibilities:

1. To manage, review and approve SOPs of the Product Assurance team to guarantee compliance with current regulatory and GMP requirements.
2. To manage and monitor the housekeeping program.
3. To manage and monitor the Pest Control program.
4. To manage all activities of batch record evaluation, lot investigation as needed and batch record documentation archival.
5. To manage retain and reference samples and relevant storage.
6. To manage all deviations investigations related to: Production process, Environmental out of specifications; Raw materials, API, packaging materials deviations; Confirmed OOS.
7. To manage and assure that all complaints investigations and final responses to the customers are completed as appropriate in terms of compliance, effectiveness and timing:
8. To manage the issuing of Certificate of analysis and relevant distribution to the customers.
9. To establish policies and procedures to guarantee compliance with current regulatory and GMP requirements.
10. To establish and maintain metrics to track quality performance within the Plant.
11. To approve Annual Product Review system assuring compliance with cGMP’s.
12. To monitor that the CAPA are completed as appropriate in terms of compliance, effectiveness and timing.
13. To ensure that the validation activities and changes are completed before batch review process has been completed;
14. To manage and approval the product/materials master data in the system SAP.

 

Position Activities:

1. To be responsible for the execution of the Pest control program.
2. To be responsible for the execution of the Housekeeping program.
3. To be responsible to maintaining GMP standards and Quality Systems, to guarantee that all manufacturing processes are in compliance with the related legal prerequisites.
4. To approval the product/materials master data in the system SAP.
5. To assess and approve all the Standard Operating Procedures having GMP impact.
6. To coordinate a team in charge of deviations, complaints investigations and CAPA.
7. To coordinate the activities of archiving and storage of batch record documentation and retain samples.
8. To monitor that the validation activities and changes are completed before batch review process has been completed.
9. To coordinate a team in charge of batch record review and support the effectiveness of the release process of all batches of semifinished and finished products manufactured at Latina facility, including all batches manufactured by third parties for which is responsible for the final release in the EU markets.
10. To approve the Annual Product Review for all products manufactured at Latina facility.
11. To review the Quality Agreements with third parties (customers and suppliers).
12. To define and manage the Section annual budget with the Head of Quality Operations.

 

The ideal candidate has University degree in technical areas (Chemistry or Pharmacy or Pharmaceutical Chemistry or Biology or Biotechnology), has deep knowledge of the quality control activities, production process, Quality Management and regulatory topics as a result of at least 6 years of experience.

Good knowledge of English language is required.

Place of work: Latina