GXP - Computerized System Validation SME

9 - 12 years

11 - 14 Lacs

Posted:5 months ago| Platform: Naukri logo

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Job Type

Full Time

Job Description


About The Role :
  • Ensure Review and Approval of planning, execution and documentation of Change Management Activities (at Asses / Review states); along with associated lifecycle documents and test documents for Change Lifecycle by maintaining the IT Compliance standards.
  • Working on Defect Management, CAPA and Deviation documentation, review and approval.
  • working on testing and validation management tools like ServiceNow, HP ALM, Document Management (GDRS/ EDMS), or equivalent tools, etc.
  • Responsible for the review and approval of Test Scripts and executed test cases to assure compliance with good documentation practices.
  • Experienced in authoring & review of validation documentation such as URS, FRS, and SDS, Validation Plan, Issues Log, Design Review, IQ Protocol/Report, OQ



  • Primary Skills
  • Validation SME
  • Ensure Review and Approval of planning, execution and documentation of Change Management Activities (at Asses / Review states); along with associated lifecycle documents and test documents for Change Lifecycle by maintaining the IT Compliance standards.
  • Working on Defect Management, CAPA and Deviation documentation, review and approval.
  • working on testing and validation management tools like ServiceNow, HP ALM, Document Management (GDRS/ EDMS), or equivalent tools, etc.



  • Secondary Skills
  • Responsible for the review and approval of Test Scripts and executed test cases to assure compliance with good documentation practices.
  • Experienced in authoring & review of validation documentation such as URS, FRS, and SDS, Validation Plan, Issues Log, Design Review, IQ Protocol/Report, OQ
  • Protocol/Report, Test Cases, Test executions, Trace Matrix, and Validation report, etc.
  • Research in supporting systems (e.g., GDRS, ServiceNow, EDMS, etc.) that store the records to be reviewed
  • Sign & Approve request forms for HPQC as IT Compliance approver.
  • Individual contributor for Quality, Compliance, and Good Documentation Practices
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