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.