Executive - CSV(QA)

Role & responsibilities

1. Risk based life cycle approach to validate GxP Computerized System as per GAMP5.
2. Hand on experience on validation of Enterprises application like LIMS, ERP, eBR ; Manufacturing system like HMI/SCADA and Laboratory system like Empower, Lab solution, Tiamo etc
3. Preparation and review validation deliverable like GxP Assessment, Vendor Assessment URS, Risk Assessment, IQ/OQ/PQ (Protocol ,script and Report), RTM, ER-ES Assessment and VSR.
4. Can independently execute the OQ script and support during IQ and PQ execution.
5. Extensive knowledge on 21 CFR Part 11 and EU Annexure 11.
6. Preparation, Review, execution and compilation of process equipments, HVAC and utilities protocols and reports.
7. Preparation, Review, execution and compilation of all the qualification protocols of laboratory and manufacturing systems
8. Initiate request for protocols and annexures.
9. Participate in FAT and SAT of process equipment's and utilities and review of vendor documents.
10. Preparation of Qualification certificates and handover the same to Documentation cell.
11. Review of all Protocols, Reports and Documents with relevant to CGMP.
12. To update validation master plan.
13. Update and Review of Logbooks.
14. To ensure CGMP compliance in all related activities.
15. Preparation, Review, execution, compilation and report preparation of General study protocols.
16. Tracking of all documents.
17. Ensure all laboratory & manufacturing activities are performed as per CGMP/GLP.
18. Preparation and Review of Periodic Review Schedule.
19. Execution and Review of Equipment and Systems Periodic Review as per Periodic Review Schedule.
20. Preparation and Review of Requalification Schedule.
21. Execution and Review of Equipment Requalification as per Periodic Requalification Schedule.

Preferred candidate profile

3-5 yrs Exp. in CSV(QA)

Exp. in laboratory, Manufacturing Equipment's, Utility systems.