Responsible for developing, establishing and maintaining QA procedures related to clinical trials to ensure compliance to applicable regulatory guidelines.
Review of Clinical Trial related documents like Investigators Brochure, Clinical Trial Protocol, Informed Consent Document, associated plans and manuals.
Ensuring the conduct of clinical trials as per applicable guidelines, SOPs and protocols
Plan, conduct, and/or lead clinical trial site audits, CRO/vendor audits, central laboratory and other critical service provider audits, facility audits, and TMF/clinical documentation audits.
Prepare audit reports and communicate observations clearly based on risk and regulatory impact.
Track and evaluate audit responses and CAPA commitments for adequacy and effectiveness to ensure timely closure of audit findings.
Responsible for the external audits/inspections and it’s CAPA resolutions and implementation.
Solid knowledge of ICH-GCP, NDCT (2019) and applicable regulations.

📌 Sr Executive Bengaluru
🏢 Aurigene Oncology
📍 Bengaluru