Computer System Validation Engineer

1. Drive the CSV strategy / plan to achieve the validated status during project stage as per the ICT SOP.

2. Perform Risk assessment and carry out Risk based testing of Computerized System.

3. Preparation and Review of Validation deliverables such as URS, GxP, VP, Specifications documents (SDS, FS, SCS), IQ Protocols and Scripts, OQ Protocols and Scripts, PQ Protocols and Scripts, TM and VSR as per the ICT SOP.

4. Execution/Support in execution of IQ, OQ and PQ test scripts.

5. Co-ordinate with Vendor and System owner to carry out Validation activity of Computerized Systems and Software.

6. Responsible for achieving & maintaining the validated status of in scope computerized systems.

7. Other Responsibilities assigned by Reporting Manager or Designee.

8. Periodic review of all GxP Software in Veeda Clinical Research.

9. Responsible to response to Audit query for the software by Regulators and Sponsors.

10. Responsible to face Internal-External as well as regulatory Audits as far as CSV activity is concerned.

11. Allocation And Removal of Operational Rights in CDS( GxP) and Non CDS( Non GxP) Applications/Softwares .

12. Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP and GCP environments.

Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure Experience.

13. Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.

14. Good communication and technical writing skills are a must.