Senior Quality Assurance Engineer m/f/d

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.

Type of employment: Payroll

Industry: Biotech

Skills: Aseptisch,Quality

Project start: 16.03.2026

Project duration: 17.07.2026

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:
  • 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.