Aurigene Oncology- looking for Clinical QA Senior Executive

Pharmaguidances; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Aurigene Oncology is seeking a Senior Executive – Clinical QA in Bangalore to ensure QA processes for clinical trials and regulatory compliance. The candidate will review essential trial documents and lead various audits to ensure high standards.

The role requires 5–8 years of Clinical QA experience with a Master’s in Pharmacology/QA/Biochemistry/Biotechnology, and strong knowledge of ICH-GCP and regulatory guidelines. This is a full-time position based in Bengaluru.

Qualifications

• 5–8 years of Clinical QA experience with a Master's degree or equivalent.
• Experience reviewing Investigators Brochure, protocols and ICFs.
• Experience conducting site, CRO/vendor, and central lab audits.

Responsibilities

• Develop, establish and maintain QA procedures for clinical trials.
• Review trial documents including ICH-GCP related plans and manuals.
• Plan and lead site audits, vendor audits and TMF audits; generate audit reports.

Skills

QA Procedures

Clinical QA

Audit Planning

Regulatory Compliance

GCP Knowledge

Education

Master’s in Pharmacology

Master’s in QA

Master’s in Biochemistry

Master’s in Biotechnology

Job description

# Aurigene Oncology- looking for Clinical QA Senior Executive#### *Aurigene Oncology- looking for Clinical QA Senior Executive*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 :*** BangaloreShare your resume at Email : tamil\\[e-mail] Views: 11**Job Category:** Pharma**Job Type:** Full Time**Job Location:** BANGALORE