Spécialiste en assurance qualité

About the role

The Quality Assurance Specialist will ensure that the Pharmaceutical Quality System (PQS) is applied and maintained in compliance with GMP/GDP regulations. Working within a cross‑functional environment, the role supports validation, risk management, and regulatory readiness for sterile manufacturing processes.

Key responsibilities

• Apply and maintain the PQS according to GMP/GDP and relevant regulations.
• Review and approve GMP documentation such as SOPs, work instructions, protocols, reports, and batch records.
• Manage deviations, CAPAs, and change controls, including assessment, investigation support, follow‑up and closure.
• Support qualification and validation review and approval activities.
• Contribute to risk assessments and the Contamination Control Strategy.
• Oversee supplier and material quality, including qualification, complaints handling, and quality agreement support.
• Support computerized system validation (CSV) – GxP classification, URS, IQ/OQ/PQ deliverables, periodic reviews, audit‑trail and access reviews.
• Ensure data integrity (ALCOA+) and compliance with Annex 11 and 21 CFR Part 11 across computerized systems.
• Assist with customer audits and regulatory inspections, from preparation to follow‑up.
• Track quality KPIs and escalate issues to management.

Required profile

• Diploma in pharmacy, chemistry, biology, biomedical sciences or a related field.
• 5+ years of QA experience in the pharmaceutical industry, preferably in sterile manufacturing.
• Strong knowledge of EU GMP (Annex 1), GDP and data‑integrity expectations.
• Hands‑on experience with deviation, CAPA and change‑control management.
• Competence in Computerized System Validation (CSV) – GAMP 5, Annex 11, 21 CFR Part 11, validation lifecycle (URS, IQ, OQ, PQ).
• Experience supporting audits and regulatory inspections.
• Familiarity with an eQMS (e.g., Scilife or similar).
• Rigorous, structured approach and ability to work autonomously with cross‑functional teams.

Required skills

• GAMP 5
• Annex 11
• 21 CFR Part 11
• Validation lifecycle (URS, IQ, OQ, PQ)
• eQMS (Scilife or similar)
• Data integrity (ALCOA+)
• GMP/GDP documentation
• Deviation, CAPA, change‑control management
• Risk assessment
• Contamination Control Strategy
• Supplier qualification
• Computerized System Validation (CSV)