CSV验证

该职位来源于猎聘 Manager—QSV (Computerised System Validation)Lead and execute CSV activities for GxP-relevant systems across Production, QC, Supply Chain, and supporting functions.Develop and maintain validation documentation including URS, FS, DS, Risk Assessments, Validation Plans, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.Ensure compliance of validation deliverables with GAMP 5 and applicable regulatory standards.Review and approve vendor documentation, qualification protocols, and validation reports.Manage system lifecycle documentation, including periodic review and revalidation activities. Engineer—QSV (Computerised System Validation)Define and implement the overall Computerised System Validation strategy and governance for the organization.Develop and maintain the CSV master plan, ensuring alignment with global and local quality systems.Establish and monitor CSV KPIs, ensuring consistent and compliant delivery of validation projects.Lead risk-based validation initiatives to optimize resources while maintaining regulatory compliance.