Test Manager & Validation Lead
Core
Own validation activities for serialization and wider IT landscape to ensure GxP systems remain validated throughout their lifecycle.
Role type
Senior Test Manager & Validation Lead
Builds
Validated GxP computerized systems
Domain
Pharmaceutical/Life Sciences IT
Required skills
GxP compliance, Computerized System Validation (CSV), validation lifecycle management, risk assessment, deviation management, test protocol design, functional and technical specification writing, serialization/traceability knowledge
Preferred skills
Serialization or traceability systems experience
Technologies
GxP systems, serialization platforms
Responsibilities
Define and manage end-to-end validation strategies and plans; Prepare and maintain validation documentation including risk assessments, plans, and reports; Coordinate and participate in test execution and review; Manage deviations, non-conformities, and follow-up actions; Ensure systems remain validated following changes; Support functional test scenarios and test data availability.
Seniority
Senior, hands-on IC