Executive - Infotech

Job Description

Primary Responsibility for IT-Computerized System Validation (CSV) function at Lupin Limited.

1. Responsible to perform Computerized System Validation activities as per GAMP5, 21 CFR Part 11, EU Annex-11, WHO Annex-5, internal approved policies and procedures.
2. Responsible to Prepare of following validation deliverables (but not limited to):
   1. Validation Protocol (VP)
   2. Validation Summary Report (VSR)
   3. System Release Certificate (SRC)
   4. Traceability Matrix
3. Responsible to Review of following validation deliverables (but not limited to):
   1. GxP assessment, EDC Assessment, Vendor audit.
   2. User Requirement Specification (URS),
   3. Functional Requirement Specification (FRS),
   4. Design or Configuration Specification (DCS)
   5. Validation Test Scripts (IQ, OQ, PQ)
   6. Risk Assessment
4. Responsible to ensure GxP computerized systems are appropriately validated and maintained as per regulatory guidance and in-house procedures.
5. Responsible for monitoring and tracking ongoing Computerized System Validations.
6. Responsible to maintain indexing of GxP computerized software system.
7. Responsible to Coordinate for Retirement of validated computerized systems (if any).
8. Responsible to Coordinate for Periodic review of validated computerized systems as per procedure.
9. Responsible for handling of Change Control, deviations, CAPA, events etc. related to validated GxP computerized systems.
10. Responsible to Ensure Good documentation practices for CSV documentation.
11. Responsible for Gap Assessment and Remediation activities.
12. Work closely with Site & Corporate Quality Function, Site and Corporate IT Functions for validation and implementation of GxP Computerized System.
13. Responsible to Handling and compliant implementation of IT Policies and procedures associated for GxP computerized systems.
14. Participate in site management review to update status on various on-going CSV implementation and related actions.
15. Support site on regulatory audits and prepare necessary mitigation plans.
16. Responsible to Provide training to site personnel on Computer system validation in-line with GAMP5, 21 CFR Part 11, EU Annex-11, WHO Annex-5, and related guidelines as required.
17. Supervise compliance of cGMP, GxP and any other applicable regulatory requirement, including EH&S requirements.
18. Complete self-training and monitor training of team members on the relevant SOPs.
19. Report any quality concern or suggestion for improvement to managers.
20. Execute and supervise all tasks and activities as per the applicable SOPs.
21. Additional responsibilities as assigned.

Work Experience

6-8 Years of relevant experience 

Education

Competencies