Job Description

Key Deliverables:

  • Develop and maintain validation plans and lifecycle documentation
  • Execute risk-based validation for regulated systems and applications
  • Support change control and continuous validation activities
  • Ensure compliance with GxP, 21 CFR Part 11, and Annex 11 requirements

Role Responsibilities:

  • Collaborate with product, design, and QA teams to ensure software readiness
  • Conduct requirement analysis and author validation artifacts
  • Monitor system performance and support incident resolution
  • Maintain validation frameworks aligned with Amgen SOPs and regulatory trends

Skills Required
Jira

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