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QA Manager

Draft and maintain the quality system, handle complaints, perform audits, draft technical agreements, check analysis certificates in order to ensure the quality of the products on the market. Manage the local QA team (3 persons).

Job content

Key responsibilities

Maintain the Quality Management System of the company:

  • Implement, monitor, maintain the system

  • Perform internal and external audits

  • Draft and follow-up of the self-inspection plan

  • Write, evaluate and communicate new procedures and work instructions

  • Responsible for all product recalls

  • Follow-up and execute preventive and corrective actions

  • Act as contact person for the Corporate QA and other external stakeholders

 

Ensure the quality and conformity of the products:

  • Manage and follow-up of the qualified person responsible for the release of our medicines

  • Administrative release

  • Evaluation of quality problems and deviations during production, packaging and / or analysis in cooperation with the QA team

  • Review of vendor qualifications

  • Obtaining import and / or export licenses for psychotropic medicines.

  • Handling of QA complaints

 

PQR’s, quality agreements and stability issues:

  • Ensure interface with Local Pharmacovigilance Officer for identification of adverse reactions / ADRs from product complaints and vice-versa.

  • Approve Quality agreements with the manufacturers

  • Approval of the Product Quality Reviews (PQR) drawn up by the QA officer (both the PQRs of the manufacturers and internal PQRs)

  • Follow-up of the Stability issues reported by manufacturers and corporate QA, checking the reports prepared by the QA compliance officer.

 

Candidate profile

Diploma: Pharmacist or other scientific Master

Preferred knowledge and skills:

  • QA experience

  • Pharmaceutical law

  • Languages: Dutch, French and English

  • PC skills: Word, Excel, Adobe, Outlook

  • Very accurate and correct

  • A real MEP (Motivation, Energy and Passion for the job)

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