Deputy Manager/Manager - Clinical QA

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

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