Computer System Validation Expert (all gender)
Core
Plan, execute, and document computer system validation activities ensuring regulatory compliance for pharmaceutical industry systems.
Role type
Computer System Validation Expert
Builds
Validated computer systems for pharmaceutical manufacturing and quality management
Domain
Pharmaceutical industry / Regulatory Compliance
Required skills
GAMP 5, GMP, GxP, FDA 21 CFR Part 11, risk analysis, audit support, system lifecycle management
Preferred skills
Experience with LIMS, MES, ERP, CTMS, EDMS
Technologies
LIMS, MES, ERP, CTMS, EDMS
Responsibilities
Plan, lead, and document validation activities per GAMP 5 and FDA 21 CFR Part 11; Ensure GxP and GMP compliance across system lifecycle; Collaborate with IT, QA, and business units for regulatory compliance; Derive validation strategies from risk analyses and support audits/inspections
Seniority
Mid-level, hands-on IC