Pankaj Kumbhare

1. Ensure GxP Compliance of all IT systems per 21 CFR Part 11, EU Annex 11, and internal SOPs.

2. Develop, implement, and maintain IT quality policies, procedures, and SOPs.

3. Review and approve computer system validation (CSV) documents**, including URS, Risk Assessment, FSD FMEA,RTM, IQ/OQ/PQ, and Validation Reports.

4. Lead or support validation projects for GxP-relevant systems such as ERP, TrackWise.

5. Ensure data integrity (ALCOA+)** principles are followed across computerized systems.

6. Conduct or coordinate periodic audits/self-inspections of IT systems to ensure compliance and identify gaps.

7. Review and manage IT QMS like deviations, incidents, and change controls, CAPA, Investigation etc. related to GxP systems.

8. Oversee backup, restore verification, disaster recovery, and system lifecycle control processes.

9. Support regulatory and internal audits as the IT Quality SME; ensure readiness of systems and documentation.

10. Maintain up-to-date records of all IT assets (hardware, software, GxP systems).

11. Collaborate with QA, QC, Manufacturing, Engineering, and IT Infrastructure to align quality expectations.

12. Review and approve IT SOPs, Qualification Protocols, SLAs, and Service Agreements

13. Conduct ITQA training for business users, IT staff, and cross-functional teams.

14. Drive continuous improvement initiatives for IT Quality processes.

15. Participate in governance meetings, project reviews, and quality steering committees.

16. Ensure proper system retirement/decommissioning procedures are followed.

17. Implement and manage core ITIL processes – Incident, Change, Problem, and Service Request.

18. Review and approve IT change requests to ensure compliance and minimal risk.

1. Validation Oversight :

-Manage end-to-end validation of GxP computerized systems (e.g., ERP, LIMS, MES).

- Approve validation documents (URS, Risk Assessment, IQ/OQ/PQ, Reports).

- Ensure compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11.

2.Change & Risk Control.

- Evaluate change controls and conduct impact assessments.

- Apply risk-based validation approach and manage revalidation needs.

3.Compliance & Audit

- Ensure data integrity (ALCOA+) in all validated systems.

- Support regulatory and internal audits as SME.

- Address CAPAs and maintain validation status inventory.

4.Cross-Functional Collaboration

- Work with QA, IT, Manufacturing, and vendors for validation activities.

- Review vendor qualification documents (e.g., IQ/OQ).

5.Governance & Training**

- Conduct CSV and data integrity training.

- Lead validation planning and continuous improvement initiatives.