Senior Manager/Deputy General Manager - IT/Quality Assurance - Pharma

Roles and Responsibilities:

- Co-ordinate and execute training of required personnel on validation procedures and guidelines for HO and manufacturing sites.

- Perform CSV activities at HO including planning and arranging validation deliverables as per CSV SOP's and ensure timely closure of validation activity.

- Perform and review of all validation deliverables as per CSV SOP and get it final approval and CQA

- Prepare and Review of CSV related SOPs to make them inline with current requirements of regulatory agencies and get its final approval with CQA.

- Prepare and review of quality risk assessments as part of various change controls, deviations, CAPAs etc, as required in coordination with CQA.

- Provide Tactical direction and guidance for changes to regulated computer systems and infrastructure

- Manage application/system vendors and third-party consultants fir CSV activities at HO

- Coordinate sit level CSV personnel for CSV activities and harmonize the CSV practices accross sites

- Assure the CSV compliance sustainability

- Facilitate site audits on CSV compliance w.r.t regulatory requirements by CQA as required

- Coordinate with HO-IT and site-IT personnel for system implementations.

- Create gap analysis and mitigation plan to close the gaps

- Support the sites for regulatory inspections and compliance responses