Deputy Qualified Person (QP) – Sterile Manufacturing
gloor & lang Pharma and Biotech Recruiting · Soleure
Description du poste
About the role
The company, a specialized pharmaceutical CDMO in French‑speaking Switzerland, seeks a Deputy Qualified Person to support batch certification and release in a small, agile sterile manufacturing site. This hands‑on position works closely with production, QC, QA and external customers.
Key responsibilities
- Support the Qualified Person in batch certification and release, including batch record review and GMP documentation approval.
- Manage deviations, investigations, CAPAs, and change controls, ensuring GMP compliance.
- Provide senior QA support to aseptic manufacturing operations and contribute to continuous improvement on the shop‑floor.
- Assist with inspections, customer audits and inspection readiness, acting as the quality interface between Production, QC, QA, Release and external customers.
Required profile
- Several years of operational QA experience in pharmaceutical manufacturing, with recent sterile/aseptic exposure.
- Substantial experience in batch review, disposition or release and prior Deputy QP or close QP involvement.
- Strong knowledge of deviations, CAPA, change control and GMP compliance.
- Fluent French and good professional English; stable industry background, preferably within a CDMO or small manufacturing organization.
Required skills
- Sterile/aseptic manufacturing processes
- Batch release and certification
- GMP documentation and compliance
- Deviation handling, CAPA, Change Control
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gloor & lang Pharma and Biotech Recruiting
Soleure
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