Quality assurance expert

Quality Assurance Expert

Quality Assurance Senior Expert – Fill & Finish / Visual Inspection

Location: Site-based - Neuchâtel, Switzerland

Department: Quality Operations

Working Pattern: Day shift with 2×8 shifts during Aseptic Process Simulations (APS)

About the Role We are seeking a Quality Assurance Senior Expert to join our Quality Operations team and support the implementation of a new Fill & Finish and Visual Inspection area within a sterile pharmaceutical manufacturing site.

This position plays a key role in ensuring GMP compliance, providing on-the-floor quality oversight, and maintaining high standards across documentation, deviation management, and aseptic operations. The role is primarily site-based, with close collaboration across Manufacturing, Engineering, Sterility Assurance, and Quality teams.

Key Responsibilities:

1. Prepare, review, and approve GMP controlled documentation
2. Review and approve Master Batch Records
3. Manage deviations related to production events using quality systems (e.g. TrackWise), including investigations, impact assessments, and CAPA definition
4. Provide QA oversight on the shop floor, including approval of aseptic interventions during Aseptic Process Simulations (APS)
5. Participate in relevant cross-functional meetings and apply the quality escalation process
6. Ensure compliance with training requirements and system access management
7. Support routine Quality Oversight activities, such as GMP tours and continuous improvement initiatives
Required Experience:
8. Master’s degree (Bac +5) in a scientific or technical discipline
9. 2–3 years of operational cGMP experience in Quality Operations
10. Experience in a pharmaceutical manufacturing environment producing sterile injectable products
11. Strong understanding of sterile manufacturing processes, from upstream activities to aseptic filling
12. Solid knowledge of cGMP requirements and Quality Systems (Deviations, CAPA, Change Control, Training, Documentation)
13. Excellent written and verbal communication skills in French and English
14. Proficient with Microsoft Office tools
15. Recognized for teamwork, autonomy, agility, and attention to detail
Day to Day:
16. Minimum 4 days per week on site
17. Occasional home office possible for specific tasks upon approval
18. Direct reporting to the QA Manager
19. High level of daily interaction with Manufacturing, Engineering, Sterility Assurance, Quality Ops, and Training teams
Please note: