GCP - Computer System Validation Specialist (12 month limited-term)
Core
Validate GCP-regulated computerized systems and software to ensure compliance with 21 CFR Part 11 and quality system principles in a pharmaceutical/biotech environment.
Role type
Computer System Validation (CSV) Specialist
Builds
Validated, compliant computerized systems for clinical trial services and medical research
Domain
Life Sciences / Clinical Research / GxP Compliance
Required skills
GxP validation, 21 CFR Part 11, validation documentation, change control, audit readiness, SDLC processes, defect management, stakeholder collaboration
Preferred skills
Automated testing tools, enterprise validation technologies, pharmaceutical/biotech industry experience
Responsibilities
Execute validation activities for computerized systems, develop and maintain validation documentation, partner with IT and Quality teams, coordinate testing activities, manage defects and deviations, train project teams on validation procedures, provide guidance on change management
Seniority
Mid-level, hands-on IC