Qa Manager, Warehouse - Alexion

Alexion, AstraZeneca Rare Disease

Dublin, Ireland
Eu gdp and gmp compliance
Warehouse quality management system
Deviation reporting and capa
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

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.
  • Oversee warehouse inspection readiness activities, act as the quality representative during regulatory health authority inspections, and track follow-up actions stemming from inspection observations.

Matching 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.

Skills & Requirements

Must-have

  • EU GDP and GMP compliance
  • Warehouse Quality Management System
  • Deviation reporting and CAPA
  • Quality risk management ICH Q9
  • GDP-compliant receipt and storage
  • Regulatory inspection readiness

Nice-to-have

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

Key Requirements

  • 3-5 years QA/Compliance management experience
  • Bachelor's degree in science or pharmacy
  • Hands-on experience in pharmaceutical/biotech warehouse

Work Rights

Not specified

Tailored Resume

Cover Letter