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:

• Prepare, review, and approve GMP controlled documentation
• Review and approve Master Batch Records
• Manage deviations related to production events using quality systems (e.g. TrackWise), including investigations, impact assessments, and CAPA definition
• Provide QA oversight on the shop floor, including approval of aseptic interventions during Aseptic Process Simulations (APS)
• Participate in relevant cross-functional meetings and apply the quality escalation process
• Ensure compliance with training requirements and system access management
• Support routine Quality Oversight activities, such as GMP tours and continuous improvement initiatives

• Master’s degree (Bac +5) in a scientific or technical discipline
• 2–3 years of operational cGMP experience in Quality Operations
• Experience in a pharmaceutical manufacturing environment producing sterile injectable products
• Strong understanding of sterile manufacturing processes, from upstream activities to aseptic filling
• Solid knowledge of cGMP requirements and Quality Systems (Deviations, CAPA, Change Control, Training, Documentation)
• Excellent written and verbal communication skills in French and English
• Proficient with Microsoft Office tools
• Recognized for teamwork, autonomy, agility, and attention to detail

• Minimum 4 days per week on site
• Occasional home office possible for specific tasks upon approval
• Direct reporting to the QA Manager
• High level of daily interaction with Manufacturing, Engineering, Sterility Assurance, Quality Ops, and Training teams

contact Rob Angrave or Adrien Guimard on info@ckqls.ch or call +41 444 990 468.

It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference 171589 in all correspondence.