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:
o Witnessing critical sterility assurance activities (e.g. sterile setup, filling)
o 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:
o Drug Substance thawing
o Compounding
o Filling
o Freeze‑drying
o Capping
o Visual inspection
o Storage
* Support the investigation, follow‑up, and closure of deviations, including associated CAPAs
* Provide daily status and progress reporting to management
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