Compliance Support QA Specialist – Deviation Management (Pharma)

About the role

We are looking for a QA Specialist focused on Deviation Management to join our Compliance Support Production team in a Fill & Finish injectable manufacturing environment. This position is a 100% maternity‑leave replacement and will work closely with Production, QA and Microbiology teams, spending time both on the shop floor and in the office.

Key responsibilities

• Perform impact assessments on product and process when deviations occur.
• Lead investigations, conduct root‑cause analyses and document findings in line with GMP requirements.
• Prepare, write and maintain deviation reports and ensure timely closure of CAPA actions.
• Conduct on‑floor (Gemba) investigations, collect evidence and review batch records to guarantee data integrity.
• Act as the primary QA contact for production teams regarding deviations.
• Support internal and external audits/inspections by organizing deviation documentation and answering auditor queries.

Required profile

• Master’s degree in biology, chemistry, biochemistry, engineering or related field, or a Bachelor’s with strong relevant experience.
• 2–3 years of experience in a GMP‑regulated pharmaceutical environment, preferably in Fill & Finish injectable manufacturing.
• Proven hands‑on experience in deviation management, investigations and root‑cause analysis.
• Fluent French; basic English.

Required skills

• Good knowledge of GMP and pharmaceutical manufacturing processes.
• Strong analytical and problem‑solving mindset.
• Excellent written communication for clear, concise deviation reports.
• Ability to work independently on deviations without junior supervision.
• Willingness to adhere to strict gowning and hygiene rules on the shop floor.