Computer System Validation Expert (all gender)
Core
Plan, execute, and document validation activities for computerized systems in the pharmaceutical industry to ensure regulatory compliance.
Role type
Computer System Validation Expert
Builds
Validated computerized systems (LIMS, MES, ERP, CTMS, EDMS) for pharmaceutical clients
Domain
Pharmaceutical industry / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
GAMP 5, FDA 21 CFR Part 11, GxP, GMP, risk analysis, audit support, system lifecycle management
Preferred skills
Experience with LIMS, MES, ERP, CTMS, EDMS
Technologies
LIMS, MES, ERP, CTMS, EDMS
Responsibilities
Plan, execute, and document validation activities; ensure GxP/GMP compliance across system lifecycle; collaborate with IT, QA, and business units; derive validation strategies from risk analyses; support audits and inspections
Seniority
Mid-level, hands-on IC