- 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 its CAPA resolutions and implementation.

- Solid knowledge of ICH-GCP, NDCT (2019) and applicable regulations.

Kindly email your resume to [email protected], if you find this opportunity is suitable to you.

📌 Deputy Manager/Manager - Clinical QA (Bengaluru)
🏢 Aurigene Oncology Limited. (a Dr. Reddy's Subsidiary)
📍 Bengaluru