Computer System Validation Consultant

Company Description

laboratory instruments

Role Description

This is a part-time remote role for a Computer System Validation Consultant. The consultant will be responsible for ensuring that computerized systems meet regulatory requirements and industry standards through validation activities. Day-to-day tasks include creating and reviewing validation documentation, conducting risk assessments, performing system testing, and managing validation projects. The consultant will work closely with cross-functional teams to ensure compliance and optimize processes.

Key Qualifications & Experience:

• 3+

  hands-on experience in

  Computer System Validation

  in GxP-regulated industries (pharmaceuticals, biotech, medical devices, or life sciences)
• Deep knowledge of

  FDA 21 CFR Part 11

  ,

  EU Annex 11

  ,

  GAMP 5

  , and

  Data Integrity

  principles
• Strong background in authoring and reviewing validation documentation such as:
• URS (User Requirements Specifications)
• FRS (Functional Requirements Specifications)
• RTM (Requirement Traceability Matrix)
• IQ/OQ/PQ Protocols
• Validation Plans and Summary Reports