Job Description

Key Deliverables:

  • Develop and execute validation plans and protocols for GxP-regulated systems
  • Ensure system documentation complies with 21 CFR Part 11, Annex 11, and CSA guidance
  • Support change control, incident handling, and periodic review for validated systems
  • Collaborate with cross-functional teams to maintain continuous validation throughout the lifecycle

Role Responsibilities:

  • Perform risk-based assessments and define validation scope and strategy
  • Coordinate user and functional requirement gathering and document reviews
  • Maintain validation artifacts using platforms like Veeva, KNEAT, or ALM
  • Provide post-deployment support and ensure ongoing system compliance


Skills Required
Sql

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