jobseeker Logo
Now Apply on the Go!
Download iimjobs Jobseeker App and get a seamless experience for your job-hunting
29/07 Sugandha Aggarwal
Senior Consultant at STM

Views:1988 Applications:57 Rec. Actions:Recruiter Actions:5

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

Mumbai Job Code: 726245

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

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

Women-friendly workplace:

Maternity and Paternity Benefits

Add a note
Something suspicious? Report this job posting.