Founded in 2001, we are a clinical-stage biopharmaceutical company focused on delivering ground-breaking cancer therapeutics to patients globally.

Post : Senior Executive – Clinical QA

Qualification & Experience
5 to 8 years of experience in Clinical QA with Masters in Pharmacology/QA/Biochemistry/ Biotechnology

Key Responsibilities
• 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.
• Strong knowledge of ICH-GCP, NDCT (2019) and applicable regulations.

Job Location : Bangalore

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