QA Specialist - Fill & Finish

Department: Bioplant Quality Assurance
Reports to: Manager, QA Fill & Finish Operations
Location: Yverdon-les-Bains
Contract: Until end 2027
Start: October 2026

Join a large-scale biological production site! You will be responsible for quality oversight of fill and finish operations for monoclonal antibodies. This role includes aseptic filling, visual inspection, and associated manufacturing activities. You will ensure compliance with Good Manufacturing Practices (GMP/cGMP), company policies, and Annex 1 of the EudraLex.

Project Phase (Design, Qualification and Commissioning)

• Documentation and Evaluation: Write, review and approve GMP documentation for new processes and equipment (SOPs, protocols, batch records). Assess the quality impact of Change Controls.

• Risk Management: Participate in risk analyses and ensure necessary controls are integrated into operations.

• Annex 1 Compliance: Ensure integration of sterility and contamination control standards into project deliverables.

• Quality Referent: Represent QA at project meetings to ensure alignment with regulatory requirements, with a "right first time" mindset.

Operational Phase (Aseptic Production)

• On-site Presence: Supervise daily aseptic filling, visual inspection, washing and sterilisation operations (including presence in classified areas).

• Batch Record Management: Review batch records within deadlines and support batch release. Approve GMP documents (SOPs, master files, etc.).

• Compliance and Improvement: Manage deviations, conduct investigations, and approve action plans (CAPA). Conduct quality rounds (GEMBA walks) and encourage continuous improvement.

• Inspections: Prepare and support activities related to health authority inspections.

• Training and Support: Assist production teams in understanding and applying GMP and Annex 1 (cleanroom behaviour, aseptic practices).

• University degree in sciences (Pharmacy, Chemistry, Biotechnology or Engineering).

• At least 3 years of experience in Quality Assurance within an aseptic pharmaceutical production site.

• Excellent knowledge of GMP (cGMP) and international regulatory requirements.

• Strong desire to develop expertise on EudraLex Annex 1 and sterility assurance principles (knowledge of isolator technology is a real asset).

• Previous experience with health authority inspections is a plus.

• Excellent analytical and problem-solving skills.

• Clear, structured and easy communication.

• Fluent French (written and spoken, site language) and good level of English.