Post- CSV ExecutiveExperience- 1 to 3 Yrs1. To follow the cGMP.2. Involve in internal and external audit and compliance the audit observation with in time.3. To ensure all computerized systems used to support GMP manufacture, are appropriately validated and controlled. Where validation and control includes appropriate specification and verification of e- data security and e-data management practice.4. Ensure computerized systems are appropriately validated.5. Provide support in implementation or upgrade project teams with (expert) computerized systems validation (CSV) guidance.6. Help project teams define appropriate computerized systems validation strategies including, stage gate deliverables.7. Lead GxP and Risk Assessment for Software tools, complex computer system, PLC- HMI/SCADA based systems.8. For New system/equipment/software installation at site, Preparation or review all levels of validation documents and technical sign off (internal or external SDLC) including :
Validation (Strategy) Plans, User Requirement Specifications.
Definition Documents, including Functional Specifications S/W Design Specifications or Configuration Documents and SOPs
CSV Protocol Qualification Documents and Test Specifications (DQ, IQ, OQ, PQ/FATS/SATS)
Traceability Matrices, Risk Analysis e. Validation Reports, Change Controls/ Events / Deviations etc.
Exception reports which identify defects or issues during test execution.
Review Vendor documentation.
9. Preparation, review and revision for CSV related SOP’s.10. Provide training on Computerized System Policies, SOP’s and hot topics to project team, team members, system owners and users.11. Work closely with the security and e-Data compliance manager to ensure requirement for electronic data security and e-data management are defined and delivered during any implementation or upgrade project.12. Reviewed scanned copies shall be maintain for completed CSV activity.Team, Reinforcement ConsultantsRequired Skills CSV, Computer System Validation, GMP, Validation, Testing, DQ, IQ, OQ, PQ, FATS, SATS
