Computer System Validation Expert (all gender)
Core
Plan, coordinate, and document validation activities for computer-based systems and software solutions according to GAMP5 and GxP requirements.
Role type
Computer System Validation Expert
Builds
Validated software and IT systems for regulated industries
Domain
Life Sciences / Regulatory Compliance
Required skills
GAMP5, GxP, GMP, EU Annex 11, FDA 21 CFR Part 11, Risk Assessment, Test Planning, Traceability Matrices, Audit Support, Role-Based Access Control
Preferred skills
Experience in regulated environments, Risk-based validation approach
Technologies
GAMP5, GxP, GMP, EU Annex 11, FDA 21 CFR Part 11
Responsibilities
Plan and coordinate validation activities, Create and maintain validation documents (Risk Assessments, Test Plans, Test Cases, Traceability Matrices), Ensure compliance with regulatory requirements, Evaluate role and access concepts, Support audits and inspections
Seniority
Mid-level, hands-on IC