Business Analyst, Serialization & Traceability L3 Expert
Core
Lead validation activities for serialization and traceability systems within the pharmaceutical IT landscape to ensure GxP compliance.
Role type
Senior Test Manager & Validation Lead
Builds
Validated GxP-compliant computerized systems for serialization and traceability
Domain
Pharmaceutical / Life Sciences / Regulatory Compliance
Required skills
GxP expertise, Computerized System Validation (CSV), validation lifecycle management, risk assessment, test protocol design, deviation management, documentation control
Preferred skills
Serialization/traceability system experience, pharmaceutical industry background
Technologies
GxP systems, validation tools, test management platforms
Responsibilities
Define and manage end-to-end validation strategies and plans, prepare and maintain validation documentation (plans, protocols, reports), coordinate test execution, manage deviations and non-conformities, ensure systems remain validated after changes
Seniority
Senior, hands-on IC