QA GMP Compliance support Consultant, Real Staffing …, Thielle-Wavre

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

#J-18808-Ljbffr