Clinical QA Auditor

  • Date Posted June 30, 2020
  • Location Hyderabad
  • Job Title Clinical QA Auditor
  • Job ID JS-QA-556
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Job Desciption

Job Description for Clinical QA Auditor:

  • Plan, conduct and mange Internal audits (Study – Inprocess & Retrospective, System Audit) and Vendor audits as per the plan in compliance with ICH-GCP, Protocol, SOPs and applicable GxP standards/ regulations.
  • Preparation of audit reports for the audits conducted and release the audit report to auditee.
  • Preparation/Review of SOPs, review of study protocols and clinical study reports
  • Assess suitability of responses to audit findings and negotiate suitable actions needed to satisfactorily resolve audit findings.
  • Review of deviations and CAPA plans and follow-up CAPA plans and ensure for its implementation and closer.
  • Assist in preparation of the facility for client/sponsor audits and regulatory inspection
  • Perform the reconciliation of Project and Non-project related documents and send for archival
  • Review the equipment calibration/validation records

 Skills/ Qualifications:

  • Strong written and verbal communication skills
  • Strong analytical and problem solving skills
  • Good computer skills
  • Self-motivated and able to prioritize the work.

 Education & Experience:

  • Education in Life Sciences (B.Sc/M.Sc/B.Pharm/M.Pharm)
  • 2- 5 years experience in GCP quality assurance audits and knowledge on ICH-GCP and US and EU regulations and applicable GxP standards/Regulations.

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