Qa Manager, Warehouse - Alexion

Alexion, AstraZeneca Rare Disease

Dublin, Ireland
Eu gdp and gmp compliance
Warehouse quality oversight
Deviation and capa management
Responsible for overseeing and assuring the quality of all activities related to the warehouse that supports the ADMF site, operating under EU GDP and relevant GMP

Job Summary

  • Responsible for overseeing and assuring the quality of all activities related to the warehouse that supports the ADMF site, operating under EU GDP and relevant GMP.
  • Maintain, and continuously improve the warehouse Quality Management System (QMS) aligned with EU GDP and GMP, including procedures, records, quality metrics, and management review.
  • Act as the quality lead on change controls for the warehouse, equipment, systems, and processes; perform quality risk management (QRM) per ICH Q9 principles for changes, deviations, and continuous improvement.

Matching Summary

Responsible for overseeing and assuring the quality of all activities related to the warehouse that supports the ADMF site, operating under EU GDP and relevant GMP.

Skills & Requirements

Must-have

  • EU GDP and GMP compliance
  • Warehouse quality oversight
  • Deviation and CAPA management
  • Quality Risk Management (QRM)
  • Regulatory inspection readiness

Nice-to-have

  • Lean/6-Sigma experience
  • Independent functioning
  • Ambiguity tolerance
  • Natural curiosity

Key Requirements

  • Bachelor’s degree in physical /life science or pharmacy
  • 3-5 years of hands-on QA/Compliance management experience
  • GxP, quality systems, and Pharmacovigilance knowledge
  • Strong verbal and written communication skills

Work Rights

Not specified

Tailored Resume

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