GCP QA Auditor Role at Syngene | Apply Online
A rare Syngene GCP QA Auditor opportunity has emerged at Syngene International Ltd for a GCP QA Auditor position in Bangalore, KA. This role is pivotal for overseeing quality management systems in clinical research, and interested candidates are encouraged to apply before the deadline.
About the company
Syngene International Ltd is a leading global provider of contract research and manufacturing services. The organization specializes in drug discovery, development, and manufacturing services for the pharmaceutical and biotechnology sectors. With a commitment to excellence and innovation, Syngene operates across various locations, including its facility in Faridabad, Haryana, India.
- Date: 10 September 2026
- Location: Bangalore, KA, IN, 560100
- Division: Essential Functions
- Designation/Position Title: GCP QA Auditor (Clinical)
- Department: GCP Quality, Syngene International Ltd.
- Location: Translational Health Science and Technology Institute (THSTI) – Faridabad, Haryana, India.
Syngene GCP QA Auditor Job Description
The Syngene GCP QA Auditor will manage the GCP quality function at the THSTI facility, ensuring compliance with national and international regulatory standards. This role involves building and scaling Quality Management Systems and implementing QA oversight for clinical First-In Human (FIH) / Phase I studies. The incumbent will play a crucial role in maintaining quality and compliance oversight in clinical operations.
Key Responsibilities
- Schedule, conduct, and manage resources for GCP QA audits to ensure compliance with regulatory requirements.
- Develop risk-based audit plans focusing on ethical conduct and adherence to protocols.
- Participate in audits of clinical activities and review documents submitted to sponsors and regulatory authorities.
- Provide oversight of GCP QA auditors to ensure compliance with Standard Operating Procedures (SOPs).
- Collaborate with clinical operations teams to resolve audit findings.
- Lead investigations of misconduct and GCP breaches.
- Perform internal process audits and maintain GCP QA team activity metrics.
- Identify and escalate critical quality issues to GCP QA Head.
Syngene GCP QA Auditor Eligibility Criteria
Education: M. Pharm in Pharmacology or QA / M.Sc or M. Tech in Basic Medical Sciences / Life Sciences / Biotechnology.
Required Skills
- Experience in Quality Assurance audits in a GCP environment.
- Strong technical knowledge in BE / BA / Phase I studies and clinical research.
- Thorough understanding of regulatory guidelines (ICH, USFDA, EMA, MHRA).
- Strategic thinking and decision-making skills in a matrix environment.
Documents Required
- Resume
- Cover letter
- Relevant certifications
How to Apply
Interested candidates can apply through the following link:
Additional Information
Syngene is an equal opportunity employer and provides reasonable accommodations for qualified individuals with disabilities. All employees are expected to demonstrate alignment with the core values of excellence, integrity, and professionalism.
Why Join Syngene
Working at Syngene offers a unique opportunity to be part of a leading organization in the pharmaceutical and biotechnology sectors. The company fosters a culture of innovation and collaboration, ensuring that employees are equipped with the latest skills and knowledge to meet evolving client expectations and regulatory standards.
This Syngene GCP QA Auditor opportunity allows qualified candidates to contribute to critical quality functions in clinical research. Interested individuals are encouraged to apply at the earliest to seize this opportunity.
