Quality Assurance Specialist – Manufacturing (Permanent)

About the role

We are seeking an experienced Quality Assurance Specialist to ensure that all manufacturing activities comply with corporate quality policies and cGMP standards. The role serves as the primary contact for production deviations and drives investigations across production, maintenance, packaging, and laboratory functions.

Key responsibilities

• Lead and manage deviation investigations, coordinating with relevant functions.
• Define, implement, and monitor corrective and preventive actions (CAPA) to meet defined deadlines.
• Handle complaint investigations and support validation/qualification documentation for the production area.
• Create, review, and update QA Operations documents, and approve GMP documents such as SOPs, specifications, protocols, and reports.
• Participate in risk analyses, change control processes, and act as auditor for self‑inspections and external audits.
• Support external audits, notified bodies, and regulatory authorities, including audit‑trail reviews of GMP systems.
• Review production and packaging batch records, release incoming consumables, and train personnel for classified areas.
• Report quality alerts promptly and collaborate with Production, Maintenance, Packaging, and other functions to resolve significant quality issues.

Required profile

• University degree in Pharmacy, Chemistry or Biochemistry.
• Minimum 5 years of quality management experience in a pharmaceutical manufacturing environment.
• Strong knowledge of cGMP, including Annex 1, and experience with lyophilized and aseptic products.
• Proven ability to lead investigations and manage indirect teams.
• Fluency in French and English.

Required skills

• cGMP / GMP compliance
• CAPA management
• Validation and qualification documentation
• Risk analysis
• Change control
• Audit (internal and external)
• Lyophilization processes
• Aseptic processing

What we offer

• Permanent full‑time position (100% time)
• Opportunity to work within a leading multinational environment
• Collaborative cross‑functional teams