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Clinical QP: Accelerate Trials, Safe Batch Certifications

Posted 1 day 2 hours ago by Alexion Pharma Spain S.L.

Permanent
Full Time
Other
Dublin, Ireland
Job Description

AstraZeneca in Dublin seeks a Qualified Person to lead batch certification for clinical supplies across biologics and small molecules. You will certify DS/DP, maintain PSFs, and ensure regulatory conformity under EU GMP Part I and Annexes 13 and 16.

You will apply risk-based decision making, review stability data, and oversee import declarations and QP declarations for non-EU manufacture. Strong leadership and cross-functional collaboration are essential.

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