Pharmaceutical Safety Expert

4 days ago


Uxbridge, United Kingdom Amgen SA Full time
About the Role

Are you passionate about ensuring the highest standards of quality and safety in pharmaceutical research? As a Pharmaceutical Safety Expert at Amgen SA, you will be responsible for planning, conducting, and reporting on risk-based R&D audits, while supporting the completion of the audit plan for GPvP suppliers/vendors and processes.

Key Responsibilities:
  • Risk-Based Audits: Plan, conduct, and report on risk-based R&D audits, ensuring compliance with global regulatory requirements for GPvP/GCP/observational research.
  • Quality Event Investigations: Investigate Quality events, including root cause analysis, design, development or Corrective and Preventive Actions (CAPAs) and Effectiveness Verifications (EVs).
  • Quality System Updates: Update records in the digital quality management system (DQMS) and track through to closure.
  • Data Management: Collate and verify objective evidence for inspection & audit driven CAPAs/EVs, and data entry into the risk assessment tool using risk assessment methodology.
What We Offer:

We offer a competitive salary range of £60,000 - £80,000 per annum, depending on experience, and a comprehensive benefits package, including flexible working options, pension scheme, and access to training and development opportunities.



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