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Senior Quality Assurance Engineer m/f/w (DE)
[17150]
aseptic processing, Fill & Finish
The Quality Assurance Senior Expert will support the Quality Operations organization during the implementation of a new Fill & Finish and Visual Inspection area. The role also includes participation in routine GMP activities related to Fill & Finish operations. The expert ensures that all information recorded in quality systems and documentation complies with current guidelines, regulatory expectations, and internal procedures. This is a site-based position, requiring regular on-site presence to support manufacturing activities and aseptic operations. Project title: Quality Engineer m/f/w Type of employment: Payroll Industry: Biotech Skills: Aseptisch,Quality Project start: 16.03.2026 Project duration: 17.07.2026 Location: Neuchâtel, Switzerland Tasks: ·Prepare, review, and approve controlled documents (SOPs, instructions, forms, specifications, revisions). ·Review deviations related to production events in quality systems (e.g., TrackWise) to ensure compliance with procedures and regulatory requirements. ·Conduct or approve investigations, impact assessments (equipment/product/material), and define appropriate CAPA actions. ·Review and approve Master Batch Records. ·Ensure adherence to escalation processes. ·Maintain accurate and compliant documentation across all relevant systems. ·Approve on-the-floor aseptic interventions performed during Aseptic Process Simulations (APS). ·Participate in GMP tours and classified area oversight activities. ·Support continuous improvement initiatives within Quality Operations. ·Attend all relevant meetings to support operational and project activities. ·Collaborate daily with Manufacturing, Engineering, Sterility Assurance, Quality Ops, Training, and other stakeholders. Qualifications: ·2–3 years of hands-on cGMP experience within a Quality Operations department on a sterile injectable pharmaceutical manufacturing site. ·Strong understanding of end-to-end production processes (from cell culture to aseptic filling), including: ounit operations oequipment ogowning oenvironmental monitoring ophysicochemical and biological laboratory tests ·Solid knowledge of cGMP requirements and Quality Systems (Deviations, CAPA, Change Control, Training, Documentation). ·Proficiency with Microsoft Office tools. ·Strong writing skills in French and English.
- Prepare, review, and approve controlled documents (SOPs, instructions, forms, specifications, revisions).
- Review deviations related to production events in quality systems (e.g., TrackWise) to ensure compliance with procedures and regulatory requirements.
- Conduct or approve investigations, impact assessments (equipment/product/material), and define appropriate CAPA actions.
- Review and approve Master Batch Records.
- Ensure adherence to escalation processes.
- Maintain accurate and compliant documentation across all relevant systems.
- Approve on-the-floor aseptic interventions performed during Aseptic Process Simulations (APS).
- Participate in GMP tours and classified area oversight activities.
- Support continuous improvement initiatives within Quality Operations.
- Attend all relevant meetings to support operational and project activities.
- Collaborate daily with Manufacturing, Engineering, Sterility Assurance, Quality Ops, Training, and other stakeholders.
- 2–3 years of hands-on cGMP experience within a Quality Operations department on a sterile injectable pharmaceutical manufacturing site.
- Strong understanding of end-to-end production processes (from cell culture to aseptic filling), including:
- unit operations
- equipment
- gowning
- environmental monitoring
- physicochemical and biological laboratory tests
- Solid knowledge of cGMP requirements and Quality Systems (Deviations, CAPA, Change Control, Training, Documentation).
- Proficiency with Microsoft Office tools.
- Strong writing skills in French and English.
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