Sr. Executive

Aurigene Oncology Limited; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Aurigene Oncology Limited in Bengaluru is seeking a qualified QA professional to join our Development Quality Assurance team. You will develop and maintain QA procedures for clinical trials to ensure compliance with applicable regulatory guidelines.

You will review core trial documents, conduct site and CRO audits, and prepare clear audit reports. You will track CAPA actions and support external audits and inspections, leveraging strong knowledge of ICH-GCP and regulatory standards.

Qualifications

• Experience implementing QA procedures for clinical trials.
• Strong knowledge of regulatory guidelines and compliance.
• Familiarity with ICH-GCP and NDA/CTC regulations.

Responsibilities

• Develop, establish and maintain QA procedures for clinical trials to ensure regulatory compliance.
• Review of Clinical Trial related documents like Investigators Brochure, Clinical Trial Protocol, Informed Consent Document, associated plans and manuals.
• Ensure conduct of clinical trials as per guidelines, SOPs and protocols.
• Plan, conduct, and/or lead site audits, CRO/vendor audits, central laboratory and other audits, facility audits, and TMF/clinical documentation audits.
• Prepare audit reports and communicate observations 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.

Skills

Clinical audits

Quality Management System (QMS)

Review & Reports

Education

Bachelor of Pharmacy (B Pharm)

Job description

• Aurigene Oncology Limited>Aurigene Oncology Limited - Bangalore>Business Services>Development Quality Assurance>Development Quality Assurance>103379>91011103

End Date 31 Oct 2026

Required Experience 5 - 8 years

Skills

Clinical audits Quality Management System (QMS) Review & Reports

Bachelor of Pharmacy (B Pharm)

Job Description

• 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.