Regulatory Compliance Associate

3 days ago


Addlestone, Surrey, United Kingdom Astellas Europe Full time

About the Role

We are seeking an experienced QA Affiliate to join our team at Astellas Europe. As a key member of our Quality team, you will be responsible for ensuring compliance with Good Distribution Practice Guidelines (GDP Guidelines) and supporting the Responsible Person Import (RPi) and the QA Lead in meeting their responsibilities and accountabilities.

The role involves performing and processing activities governed by GDP Guidelines, including QA oversight of product storage and distribution, nonconformance management, product complaint handling, change control, supplier management, and annual product review. The estimated salary for this position is around €58,000 - €68,000 per year, depending on location and experience.

Key Responsibilities:

  • Perform and process activities governed by GDP Guidelines
  • Implement improvements to correct inefficiencies and non-conformances
  • Support inspection management for the wholesale dealer license
  • Represent Affiliate QA in project teams and act as a role model for Quality Culture

Essential Knowledge & Experience:

  • Relevant transferable skills in a comparable role in the pharmaceutical industry
  • Understanding of implementation and understanding of GDP, GMP, and Quality Management Systems
  • Good organizational, coordination, presentation, and communications skills
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