Aurigene Oncology -Hiring Clinical QA Dy. Manager / Manager Apply

Pharmaguidances; India; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Aurigene Oncology seeks a Dy. Manager / Manager – Clinical QA to develop and maintain QA processes for clinical trials, ensuring compliance with global guidelines. You will review critical trial documents and lead various audits across sites, CROs, and labs, driving CAPA resolutions.

The role requires 10–15 years of experience and a Master’s in Pharmacology, QA, Biochemistry or Biotechnology, with strong knowledge of ICH-GCP and regulatory standards.

Qualifications

• Master’s degree in Pharmacology, QA, Biochemistry or Biotechnology.
• Strong knowledge of ICH-GCP and applicable regulations.
• Experience in planning and conducting clinical trials audits.

Responsibilities

• Develop, establish and maintain QA procedures for clinical trials in line with regulatory guidelines.
• Review Investigator’s Brochure, Clinical Trial Protocol, ICF and related plans.
• Ensure conduct of clinical trials per SOPs and protocols.
• Plan and lead site audits, CRO/vendor audits, central lab and TMF audits.
• Prepare audit reports and communicate observations with risk-based impact.
• Track audit responses and CAPA commitments for timely closure of findings.
• Manage external audits/inspections and CAPA resolutions.

Skills

QA procedures

Audit planning

Regulatory compliance

ICH-GCP

CAPA management

Audit reporting

Audit follow-up

Education

Master’s in Pharmacology / QA / Biochemistry / Biotechnology

Job description

Aurigene Oncology -Hiring Clinical QA Dy. Manager / Manager Apply

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.

Last Date : 30th October 2026india