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
- Positive 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.

📌 Clinical QA Auditor (India)
🏢 Jeevan
📍 India