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Qualified Person (Clinical), External Quality Operations

Alexion Pharmaceuticals
Full time Dublin, County Dublin Life, Physical, and Social Science Technicians
Posted:
February 25, 2026
Location:
Dublin, County Dublin, Ireland

Job Description

Introduction to role:

This role focuses on Qualified Person responsibilities for investigational medicinal products, with an emphasis on QP release of a range of products (Biologics/Small Molecule/Polypeptides) used in EU/EEA clinical trials. The position is suited to a qualified/eligible QP who may be early in their career with previous QA clinical experience. You will build the evidence base and exercise independent, risk‑based judgement to certify DS and DP in accordance with EU GMP (Part I), Annex 13 and Annex 16, and the Clinical Trials Regulation (EU) No 536/2014. 

Accountabilities

  • Batch certification (DS and DP): Conduct QP review of batch documentation, analytical results, deviations/OOS/OOT, change controls, and validation status; confirm compliance with the IMPD/CTA, approved specifications, and technical instructions; certify DS and DP batches for clinical use within scope of authorisation as laid down in EU GMP and in accordance with Anne...

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    Job Overview

    Job Type: Full time
    Location: Dublin, Ireland
    Posted: February 25, 2026
    Deadline: April 06, 2026