Quality Assurance Manager (with Clinical and QMS exp.) - BA/BE study

5 - 10 years

2 - 6 Lacs

Posted:-1 days ago| Platform: Naukri logo

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Work Mode

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Job Type

Full Time

Job Description

Role & responsibilities

  • QMS role
  • Preparation and overview of audit plan and conduct audits (In- process audit and retrospective audits) for clinical studies.
  • Perform Retrospective audit of completed clinical study data including ICF, Individual CRF, Scanned CRF, TMF, eCTD and other relevant project specific documents etc.
  • Quality review of Clinical study reports, Randomization schedule, study updates, ICD, screening records, etc.
  • Preparation, issuance of audit reports.
  • Prepare and review of SOP
  • Compliance and verification of study audit response and closure of audit reports.
  • Review Draft ICF, CRF, protocol and related documents before IEC approval.
  • Planning and conducting of system audit and vendor audits.
  • Requisition & Issuance of documents.
  • Review equipment/instrument calibration record, IQ/OQ/PQ report.
  • Provide training to new recruits in QA department.
  • Any other task assigned by the Management.

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