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GxP Validation Analyst

2 weeks ago


London, Greater London, United Kingdom 9nexus Full time £40,000 - £60,000 per year

Job Title: GxP Validation Analyst

Role Overview:

We are looking for experienced GxP Validation Analysts to support Life Sciences projects. The candidate will ensure compliance with 21 CFR Part 11 by managing validation processes, documentation, and change control activities.

Key Responsibilities:

  • Perform IQ/OQ for machine control systems and system upgrades in HP ALM.
  • Validate machine domain transitions from Business to Manufacturing.
  • Update DIA and SOPs, author and maintain validation documentation (VP, RTM, VSR, OQ Protocols) in CDOCS.
  • Manage GxP and ServiceNow change control workflows.
  • Collaborate with Business teams for RS documents and OQ script authoring/execution.
  • Coordinate on CRs, CSRs, and validation activities with SMEs.

Required Skills (One-word):

  • GxP
  • Validation
  • Documentation
  • ALM
  • ChangeControl
  • SOPs