Explore exciting pharma jobs in India with Syngene International. Join as Group Lead in Clinical QA for GCP compliance in clinical trials and bioequivalence studies. Ideal for pharmaceutical careers in Bangalore.
About the Company
Syngene International Limited, a subsidiary of Biocon, is a leading global contract research, development, and manufacturing organization (CRDMO). Established in 1993, the company delivers integrated scientific solutions across drug discovery, development, and commercial production.
Serving pharmaceutical, biotechnology, and nutrition clients worldwide, Syngene emphasizes innovation, regulatory compliance, and scientific excellence. With state-of-the-art facilities in Bengaluru, it supports end-to-end services while maintaining the highest standards of quality, integrity, and safety.
Job Details
- Company Name: Syngene International Limited
- Qualification: M.Sc./M.Pharm/M.Tech in Basic Medical Sciences/Life Sciences/Biotechnology
- Location: Bengaluru, Karnataka, India (560100)
Job Description
Syngene International seeks an experienced professional for its Clinical Quality Assurance team within the Translational & Clinical Research Services operating unit. This leadership role focuses on ensuring GCP compliance across bioequivalence studies, clinical trials (Phase I-III), and clinical data management.
The position involves managing a team of GCP QA auditors and driving audit-ready systems.
Group Leader GCP – QA (Clinical)
- Position Title: Group Leader GCP – QA (Clinical)
- Job Level: Thought Leader
- Department: Quality Assurance (Clinical/Translational & Clinical Research)
- Role: Lead GCP QA audits and compliance for clinical operations
- Education/Qualification: M.Sc./M.Pharm/M.Tech in Basic Medical Sciences/Life Sciences/Biotechnology
Skills/Qualifications
- Expertise in performing and managing Quality Assurance audits in GCP environment
- Strong technical knowledge in BE/BA studies, clinical research, drug development, basic medical sciences, and pharmacology
- Thorough understanding of regulatory guidelines including ICH, USFDA, EMA, and MHRA
- Strategic thinking with goal-oriented approach and strong decision-making in matrix environments
- Excellent communication and collaboration skills for professional interactions
Key Responsibilities
- Schedule and conduct GCP QA audits for clinical operations
- Develop risk-based audit plans focusing on ethics and compliance
- Oversee study-based, process, site, and database audits
- Review audit reports and ensure effective CAPA plans
- Collaborate on external audit resolutions and lessons learned
- Perform vendor audits and follow-up on corrective actions
- Lead investigations into GCP breaches and noncompliance
- Escalate critical quality issues appropriately
- Conduct root cause analysis and CAPA processes
- Maintain GCP QA metrics and support regulatory inspections
Benefits/Perks
- Opportunities for career growth in a global CRDMO
- Continuous learning through technical and scientific training
- Competitive salary and comprehensive benefits package
- Inclusive and professional work culture emphasizing excellence
- Global exposure working with international clients and teams
- Strong focus on employee safety, health, and data integrity
How to Apply
Interested candidates should apply online through the official Syngene careers portal. Visit https://careers.syngeneintl.com/ or https://www.syngeneintl.com/careers/ to search for the Group Lead – Clinical Quality Assurance position and submit your application.
Verified Post
Verification: To confirm the legitimacy of this posting, you can view the original announcement on the Syngene LinkedIn page.
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Don’t miss this chance to advance your pharmaceutical career with a leader in clinical research—apply today!
Why You Should Join
Syngene fosters a culture of excellence, integrity, and professionalism while prioritizing environment, health, and safety. As a rapidly growing organization with global clients, it offers long-term career stability and opportunities to contribute to innovative drug development.
Employees benefit from a collaborative environment that promotes continuous improvement, regulatory compliance, and scientific advancement in a dynamic pharma landscape.
FAQs
What qualifications are required for this role?
A Master’s degree (M.Sc./M.Pharm/M.Tech) in Basic Medical Sciences, Life Sciences, or Biotechnology is mandatory, along with expertise in GCP audits and clinical research regulations.
How can I apply for this pharma job at Syngene?
Is prior experience in clinical QA mandatory?
The role requires demonstrated expertise in GCP Quality Assurance audits and thorough knowledge of clinical development regulations, suitable for seasoned professionals.
What growth opportunities are available?
Syngene offers leadership roles, global project exposure, continuous training, and career progression in a compliant and innovative environment focused on pharmaceutical excellence.