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. Track Wise), 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

Required Experience:

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

Day to Day:
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

Please note:

To apply , please contact Rob Angrave or Adrien Guimard on (email address removed) or call (phone number removed).
It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference (phone number removed) in all correspondence