Quality Operations Senior Specialist – Sterile Manufacturing
Listed on 2026-10-14
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Quality Assurance - QA/QC
Production QC/QA, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers
For an international pharmaceutical company in the French-speaking part of Switzerland, we are looking for an experienced Quality Operations professional with a strong background in sterile pharmaceutical manufacturing and batch release activities.
The role supports Quality Operations within an international External Manufacturing environment, with a particular focus on sterile drug product manufacturing, batch documentation and product disposition. We are looking for someone who already brings relevant hands‑on Quality and sterile manufacturing experience and is ready to broaden their expertise and take on increasing responsibility within product release and Quality Operations.
Start: ASAP | Duration: 12 months
Your Responsibilities- Perform Quality Operations activities supporting sterile drug product manufacturing
- Review batch documentation and support batch release / product disposition activities
- Review and assess deviations, investigations, CAPAs and change controls
- Ensure compliance with cGMP requirements, internal procedures and applicable regulatory standards
- Review quality and validation documentation and identify potential compliance gaps
- Work closely with external manufacturing partners and internal cross‑functional teams to resolve quality issues
- Support inspection and audit readiness activities
- Maintain relevant quality and disposition information in applicable systems
- Escalate quality or compliance risks where appropriate
- Contribute to continuous improvement and other product quality activities
- BSc/MSc or equivalent degree in a scientific or pharmaceutical discipline
- Several years of professional experience in pharmaceutical Quality Operations / Quality Assurance
- Hands‑on experience in sterile / aseptic pharmaceutical manufacturing is required
- Experience with batch record review and batch release / product disposition
- Solid working knowledge of GMP quality processes including deviations, investigations, CAPAs and change controls
- Experience in biologics drug product and/or External Manufacturing is an advantage
- Experience with SAP and electronic Quality Management Systems is beneficial
- Ability to work independently while being willing to learn and further develop within Quality Operations
- Strong analytical skills and a structured, quality‑focused working style
- Excellent English skills (C1–C2) are mandatory
- Additional German skills are an advantage, French is an asset
You are an experienced and hands‑on Quality professional who combines a solid sterile manufacturing background with a strong interest in further developing your expertise in batch release and Quality Operations. You enjoy working across teams, take responsibility for product quality and are comfortable in an international GMP environment.
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