Qualified Person, Clinical Quality & IMP Release (EU)

AstraZeneca in Dublin seeks a Qualified Person to certify DS and DP for EU trials, ensuring compliance with IMPD/CTA and Annex 16. You will oversee batch records, investigations and CAPAs, and collaborate with development and regulatory teams to maintain readiness for inspections.

Ideal candidates have 5+ years in cGMP DS/DP manufacturing, strong risk management, and experience with contract manufacturing, SAP, and Veeva Vault. This role demands leadership and meticulous documentation.