Reinforcement Consultants
Location
Faridabad | India
Job description
Post- CSV Executive
Experience- 1 to 3Yrs
- To follow the cGMP.
- Involve in internal and external audit and compliance the audit observation with in time.
- 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.
- Ensure computerized systems are appropriately validated.
- Provide support in implementation or upgrade project teams with (expert) computerized systems validation (CSV) guidance.
- Help project teams define appropriate computerized systems validation strategies including, stage gate deliverables.
- Lead GxP and Risk Assessment for Software tools, complex computer system, PLC- HMI/SCADA based systems.
- 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.
- Preparation, review and revision for CSV related SOP’s.
- Provide training on Computerized System Policies, SOP’s and hot topics to project team, team members, system owners and users.
- 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.
- Reviewed scanned copies shall be maintain for completed CSV activity.
Team,
Reinforcement Consultants
Job tags
Salary
