Summary of Position
Ensure Curium's compliance with the requirements of Good Manufacturing PracticeTake ownership, maintain and continuously improve the site Quality Management System (QMS), ensuring alignment with current regulations, guidelines and industry standards along with the site QPs
Note: The vacancy is a maternity cover (fixed-term contract).
Essential Functions
Ensure ongoing compliance with EU GMP Annex 1, Annex 3, Annex 11, Annex 16, HPRA, EMA regulations and Curium requirements.Take ownership and maintain various aspects of the Quality Management System for PET radiopharmaceutical production.Review, approve and manage deviations, CAPAs, Risk Assessments, root cause investigations, Change Controls, OOS/OOT, Complaints, recalls, withdrawals, Quality Agreements and Supplier Agreements.Provide quality oversight for new product and techno...