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
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