Clinical QP: Accelerate Trials, Safe Batch Certifications
Posted 1 day 4 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.