QA GMP Compliance support Consultant H/F/X

Description de la fonction

As a QA GMP Compliance Support, you will act as a Person-in-Plan (PIP) at a Contract Manufacturing Organization (CMO) in Germany. You will provide on-site quality oversight of clinical drug product manufacturing activities and ensure compliance with GMP requirements and applicable Quality Agreements.

A leading global pharmaceutical organisation, recognised for its high standards in quality, GMP compliance, and patient safety, operating in a highly regulated environment and working closely with external manufacturing partners for the production of pharmaceutical products, including sterile drug products.

Key Responsibilities Ensure that clinical batches are manufactured in compliance with GMP standards and Quality Agreements Act as a QA PIP at the CMO, providinghands-on oversight by: Witnessing critical sterility assurance activities (e.g. sterile setup, filling) Performing GEMBA walks when required to ensure process compliance Escalate critical quality issues and support impact assessments in collaboration with the CMO Oversee Drug Product manufacturing processes, including: Drug Substance thawing Compounding Filling Freeze-drying Capping Visual inspection Storage Support the investigation, follow-up, and closure of deviations, including associated CAPAs Provide daily status and progress reporting to management

Profil

University degree in a scientific discipline (Pharmacist, PhD in Life Sciences, Bio-Engineer, or equivalent) Relevant experience in the pharmaceutical industry within a GMP environment Experience in QA and/or Production, with strong exposure to quality systems and/or batch release Strong knowledge of: Drug Product manufacturing technologies GMP compliance Sterility assurance Fluent in English (written and spoken); German is a plus Excellent communication and influencing skills Willingness to be largely onsite at the CMO in Germany (90-100% presence)

Compétences linguistiques

• Français (atout)

  • Comprendre : Expérimenté - (C1)
  • Écrire : Expérimenté - (C1)
  • Lire : Expérimenté - (C1)
  • Parler : Expérimenté - (C1)

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