Founded in 2001, we are a clinical-stage biopharmaceutical company focused on delivering ground-breaking cancer therapeutics to patients globally.
Post : Dy. Manager / Manager – Clinical QA
Experience : 10 to 15 years
Qualification : Master’s in Pharmacology / QA / Biochemistry / Biotechnology
Required skills :
• Responsible for developing, establishing and maintaining QA procedures related to clinical trials to ensure compliance with applicable regulatory guidelines.
• Review clinical trial-related documents like Investigator’s Brochure, Clinical Trial Protocol, Informed Consent Document, associated plans and manuals.
• Ensure 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 external audits/inspections and CAPA resolutions and implementation.
• Strong knowledge of ICH-GCP, NDCT (2019) and applicable regulations.
Share your resume at Email : tamil_s@aurigene.com
Last Date : 30th October 2026
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