• Senior Manager/DGM - IT/Quality Assurance - Pharma Jobs in Mumbai,India

  • STM
  • Save Job
  • 17 - 18 Years
  • Posted : above 1 month

Job Description:

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 SOPs 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 Lupin sites

- Assure the CSV compliance sustainability

- Facilitate site audits on CSV compliance wrt 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

Profile Summary:

Employment Type : Full Time
Salary : Not Mentioned
Deadline : 07th Jan 2020

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