Quality Assurance Senior Expert â Fill & Finish / Visual Inspection
đ Location: Site-based - NeuchĂątel, Switzerland
đ Department: Quality Operations
đ Working Pattern: Day shift with 2Ă8 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
Required Experience:
* Masterâs degree (Bac +5) in a scientific or technical discipline
* 2â3 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
To apply, please contact Rob Angrave or Adrien Guimard on info@ckqls.ch or call +41 444 990 468
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