Quality Operations Senior Specialist – Sterile Manufacturing

About the role

This 12‑month temporary position supports Quality Operations in an international external manufacturing environment, focusing on sterile drug product manufacturing, batch documentation and product disposition. The role is based in the French‑speaking part of Switzerland and requires hands‑on experience in sterile manufacturing and batch release.

Key responsibilities

• Perform Quality Operations activities supporting sterile drug product manufacturing.
• Review batch documentation and support batch release and product disposition activities.
• Assess deviations, investigations, CAPAs and change controls.
• Ensure compliance with cGMP, internal procedures and regulatory standards.
• Work with external manufacturing partners and internal teams to resolve quality issues.
• Support inspection and audit readiness and maintain quality information in relevant systems.

Required profile

• BSc/MSc or equivalent in a scientific or pharmaceutical discipline.
• Several years of experience in pharmaceutical Quality Operations/Assurance.
• Hands‑on experience in sterile/aseptic manufacturing and batch record review.
• Strong knowledge of GMP processes, deviations, investigations, CAPAs and change controls.
• Excellent English (C1‑C2); German and French are a plus.

Required skills

• SAP
• Electronic Quality Management Systems (eQMS)