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
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.