Executive R&D Quality | Sun Pharma | Vadodara

Manufacturing, QA/QC/QMS/IPQA/CQA, Research & Development
Gujarat
March 21, 2023
Full Time
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Job Overview

  • Date Posted
    March 21, 2023
  • Location (State / UT)
    Gujarat
  • Expiration date
    --
  • Experience
    5 Years, 7 Years
  • Gender
    Any
  • Desired Qualification
    Master’s Degree

Job Description

Executive R&D Quality – (Commercial QA and QMS)

Roles and Responsibilities:

  • To assist in developing procedures / Quality systems and assure compliance of the same by identifying gaps through document review and Audits.
  • To review and approve QMS documents for cGxP compliance and centralized QA oversight for GMP Laboratories.
  • Review documents, approve discrepancy notes, and handle quality activities of the Medicinal Product Store to ensure compliance with cGMP requirements.
  • Review / Author SOPs for the compliance of the cGMP requirements and monitoring its implementation.
  • Ensure the periodic activities as per the quality procedures are performed in a timely manner.
  • Review and monitor In-vitro BABE study to ensure compliance with regulatory requirements and established procedures.
  • Responsible to ensure GxP Computerized Systems at GxP laboratories, are in compliance with the current regulatory standards.
  • Ensure implementation of relevant Quality Policies, Standards, and procedures for computerized systems
  • Act as Process Quality Lead (PQL) for Validation of computerized system.
  • Review and approve of inventory of computerized systems and infrastructure, at the site and ensure its compliance status.
  • Author / review the site Computerized System Validation Master Plan (CSVMP) as per the quality procedure.
  • To review and approve external sample analysis reports.
  • Review and Approve validation deliverables and lifecycle documentation for the computerized system as a Process Quality Lead.
  • Review and approve System release and retirement documents as per the quality procedures.
  • Ensure the availability of the site CSVMP as per the quality procedure.
  • Perform the GxP computerized systems assessment and ensure 21 CFR part 11, EU Annex 11 readiness, adequate security, and controls.
  • Mentoring and supporting site cross-functions to resolve issues.
  • To assess the compliance level of all the GxP departments through the Self Inspection / Internal Audit program. To support all-time readiness for successful regulatory inspection at R&D.
  • Lead the assessment, tracking of remediation, and monitoring of identified actions as part of various Corporate initiatives.
  • Present/discuss and define the way forward for fast-track remediation of open action items in site QRB meetings.
  • Perform other duties as assigned by the Functional Head from time to time.

Qualification: M.Pharma, MS/M.Sc(Science)

Experience: 5-7 Years

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