Qa Manager, Warehouse - Alexion

Alexion, AstraZeneca Rare Disease

Dublin, Ireland
On-site
Eu gdp and gmp compliance
Warehouse quality management system (qms)
Deviation reporting and root cause analysis
Alexion, part of AstraZeneca Rare Disease, is seeking a QA Manager for their Dublin warehouse to ensure compliance with Good Distribution Practice and Good Manufacturing Practice in pharmaceutical operations. The ideal candidate will have strong experience in quality assurance within the pharmaceutical industry and a proactive approach to risk assessment and continuous improvement

Job Summary

  • The QA Manager is 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

Match Score: 85

Alexion, part of AstraZeneca Rare Disease, is seeking a QA Manager for their Dublin warehouse to ensure compliance with Good Distribution Practice and Good Manufacturing Practice in pharmaceutical operations. The ideal candidate will have strong experience in quality assurance within the pharmaceutical industry and a proactive approach to risk assessment and continuous improvement.

Skills & Requirements

Must-have

  • EU GDP and GMP compliance
  • Warehouse Quality Management System (QMS)
  • Deviation reporting and root cause analysis
  • Change control and risk management
  • Audit and inspection readiness

Nice-to-have

  • Lean/6-Sigma experience
  • Ability to operate amid ambiguity
  • Natural curiosity to learn

Key Requirements

  • 3-5 years of QA/Compliance management experience
  • Bachelor's degree in physical/life science or pharmacy
  • Experience in pharmaceutical/biotech industry
  • Knowledge of GxP and quality systems

Work Rights

Not specified

Tailored Resume

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