Risk Management Professional

2 days ago


Uxbridge, United Kingdom Amgen SA Full time
About the Opportunity

As a Risk Management Professional at Amgen SA, you will have the opportunity to make a significant impact on the safety and quality of our observational research studies. Your primary responsibility will be to plan, conduct, and report on risk-based R&D audits, while supporting the completion of the audit plan for GPvP suppliers/vendors and processes.

Key Responsibilities:
  • Risk Assessment and Mitigation: Identify and mitigate risks associated with 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 Maintenance: Update records in the digital quality management system (DQMS) and track through to closure.
  • Data Analysis: Collate and verify objective evidence for inspection & audit driven CAPAs/EVs, and data entry into the risk assessment tool using risk assessment methodology.
Benefits:

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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