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Deputy Qualified Person (QP) – Sterile Manufacturing

gloor & lang Pharma and Biotech Recruiting · Soleure

New
CDI Senior 🇬🇧 English
GMP compliance batch certification batch release CAPA Change Control sterile manufacturing aseptic manufacturing

Job description

About the role

This position supports the Qualified Person (QP) in batch certification and release for a specialized pharmaceutical CDMO in French‑speaking Switzerland. It combines hands‑on batch release duties with operational QA support for sterile/aseptic manufacturing, offering high visibility across the site.

Key responsibilities

  • Support the QP 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 sterile/aseptic production, assist with inspections, customer audits and inspection readiness.
  • Act 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.
  • Strong background in batch review, disposition and release, and proven involvement in QP release activities.
  • Fluent French and good professional English.
  • Ability to work independently, make decisions on the shop floor and drive continuous improvement.

Required skills

  • GMP compliance and documentation.
  • Batch certification and release processes.
  • Deviations, investigations, CAPA and Change Control management.
  • Sterile/aseptic manufacturing knowledge.

Questions fréquentes

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Le contrat proposé est un CDI basé à Soleure.

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Published 2 days ago

Expires 1 month from now

10 views · 0 interested

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gloor & lang Pharma and Biotech Recruiting

Soleure