Compliance Support Pharma (F/M/X)

About the role

Join a dedicated Compliance Support Production team in a Fill & Finish injectable manufacturing environment. As a QA Specialist focused on Deviation Management, you will ensure GMP compliance by handling end‑to‑end deviation processes and supporting audits.

Key responsibilities

• Perform impact assessments, lead investigations, and conduct root‑cause analyses for manufacturing deviations.
• Prepare, write, and maintain deviation documentation in line with GMP and internal procedures.
• Ensure timely closure of deviations and drive corrective and preventive actions (CAPA).
• Conduct on‑the‑floor (Gemba) investigations, review batch records, and act as the primary QA contact for production teams.
• Support internal and external audits/inspections by organizing deviation‑related documentation and answering auditor queries.
• Split time between office analysis, field investigations, and coordination with Production, QA, and Microbiology while adhering to strict GMP gowning rules.

Required profile

• Master’s degree in biology, chemistry, biochemistry, engineering or related field, or a Bachelor’s degree with strong relevant experience.
• 2–3 years of experience in a GMP pharmaceutical environment, preferably in Fill & Finish or injectable manufacturing.
• Proven hands‑on experience in deviation management, investigation, root‑cause analysis, and documentation.
• Ability to work independently on deviations without junior supervision.
• Fluent French (mandatory) and good English proficiency.

Required skills

• Strong knowledge of GMP and pharmaceutical manufacturing processes.
• Expertise in Deviation Management, Root Cause Analysis, CAPA, and Batch Record Review.
• Experience with Fill & Finish and injectable manufacturing operations.
• Audit and inspection support capabilities.