For one of our clients in the pharmaceutical industry, we are looking for a QA Officer Packaging to support a QA Field team within a packaging environment focused on combination product assembly. You will contribute to ensuring GMP compliance and quality oversight of manufacturing activities, with a strong focus on prefilled syringes assembled into autoinjectors and safety syringes.
Your Mission
- Act as QA Subject Matter Expert (SME) for packaging and combination product assembly processes.
- Provide operational QA support within a manufacturing environment, ensuring compliance with GMP requirements and internal quality standards.
- Review and approve deviations, CAPAs, investigations, complaints and Change Controls.
- Provide QA oversight for equipment qualification and validation activities related to new or modified manufacturing equipment.
- Review and approve qualification protocols, validation documentation, cleaning validation and process validation reports.
- Support risk management activities, including pFMEA and quality risk assessments.
- Contribute to Continued Process Verification (CPV) and Product Quality Review (PQR) activities.
- Participate in audits, market complaint investigations and operational quality improvement initiatives.
- Collaborate closely with Production, QC, Regulatory Affairs, Supply Chain, Validation, Engineering and Procurement teams.
- Adapt priorities according to manufacturing needs while maintaining a strong quality mindset and shopfloor presence.
Your Profile
- Master's degree in a scientific discipline.
- 3 to 8 years of operational QA experience within the pharmaceutical industry.
- Proven experience with pharmaceutical quality systems, including deviations, investigations, CAPAs, complaints and Change Controls.
- Strong hands-on experience in equipment qualification and process validation activities, including CSV, PQR, CPV and pFMEA.
- Demonstrated ability to review and approve qualification protocols and validation documentation.
- Experience in a GMP-regulated manufacturing environment with strong interaction with production teams.
- Experience in packaging QA or combination products is considered a strong asset.
- Knowledge of autoinjectors, safety syringes or medical-device-related environments is highly valued.
- Previous experience with SAP and electronic Quality Management Systems (eQMS) is an advantage.
- Familiarity with statistical analysis and collaboration with validation/statistics teams is a plus.
- Fluent in French and English, both written and spoken.
- Team-oriented, proactive and comfortable working in a dynamic operational environment with changing priorities.
What We Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive compensation package. You will also benefit from technical training and professional development opportunities to strengthen your expertise and support your long-term career development.
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