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Qualified Person, Clinical Quality Operations Lead

Posted 10 days 21 hours ago by AstraZeneca GmbH

Permanent
Full Time
Other
Dublin, Ireland
Job Description

AstraZeneca GmbH in Dublin is seeking a Qualified Person to certify IMPs across biologics, small molecules, and polypeptides for EU/EEA clinical trials. You will ensure batches are safe, compliant, and released on time, serving as the certifying authority in a highly regulated environment.

You will lead QP reviews, maintain PSFs, oversee regulatory conformity, and apply risk management while coordinating with CMOs, QA, and Supply Chain to sustain product quality from manufacture to investigator

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