Senior Consultant at STM
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Senior Manager/Deputy General Manager - IT/Quality Assurance - Pharma (9-15 yrs)
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
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