Qualified Person (M/F)

In a pharmaceutical environment (GMP), you will ensure the review, certification, and release of batches of active substances and finished products, both clinical and commercial. As the guarantor of batch compliance, you will base your decisions on manufacturing and control records, regulatory requirements, and customer commitments. You will work cross-functionally with operational teams and report to the Department Manager and the Pharmacien Responsable.

Job Missions:

• Perform the pharmaceutical review of manufacturing, packaging, and control records
• Verify the compliance of analytical results and documents associated with batches
• Evaluate the impact of deviations, OOS/OOT, Change Controls, and CAPA on batch release
• Ensure control of quality events before any release decision
• Ensure, according to applicable delegations, the certification and release of clinical and commercial batches
• Issue and approve release documents and certificates
• Pronounce or propose the release, hold, or rejection of batches
• Guarantee the traceability and justification of pharmaceutical decisions
• Act as the QA interlocutor for Production, Quality Control, Supply Chain, Regulatory Affairs teams, and clients
• Participate in client audits, regulatory inspections, and continuous improvement actions

Required Skills:

• Doctor of Pharmacy, thesis defended
• Registered or eligible for registration in Section B of the Ordre national des pharmaciens
• Experience in Product Quality Assurance, batch record review, and pharmaceutical release
• Good mastery of GMP and requirements related to batch certification and release
• Experience in biological medicines, active substances, or investigational medicinal products is appreciated
• Analytical capacity, critical thinking, and ability to make documented and independent decisions
• Good level of written and spoken English
• Rigor, reactivity, sense of responsibility, and ability to work cross-functionally