Clinical QA Auditor

As a Clinical QA Auditor, your role involves planning, conducting, and managing internal audits (Study Inprocess & Retrospective, System Audit) and Vendor audits in compliance with ICH-GCP, Protocol, SOPs, and applicable GxP standards/regulations. You will be responsible for preparing audit reports, reviewing SOPs, study protocols, clinical study reports, deviations, and CAPA plans. Additionally, you will assist in preparing the facility for client/sponsor audits and regulatory inspections, perform reconciliations of project and non-project related documents, and review equipment calibration/validation records. Key Responsibilities: - Plan, conduct, and manage internal and vendor audits according to the audit plan - Prepare audit reports and release them to auditees - Review and prepare/revise SOPs, study protocols, and clinical study reports - Assess responses to audit findings and negotiate suitable actions - Review deviations and CAPA plans, follow-up on implementation, and ensure closure - Assist in facility preparation for client/sponsor audits and regulatory inspections - Perform reconciliation of project and non-project related documents - Review equipment calibration/validation records Qualifications Required: - Education in Life Sciences (B.Sc/M.Sc/B.Pharm/M.Pharm) - 2-5 years of experience in GCP quality assurance audits - Knowledge of ICH-GCP, US and EU regulations, and applicable GxP standards/regulations As a Clinical QA Auditor, you should possess strong written and verbal communication skills, analytical and problem-solving abilities, good computer skills, and self-motivation to prioritize work effectively.,