Clinical Job at Syngene in Bangalore | Medical Science Candidates Apply
Syngene Careers presents a senior Clinical Job opportunity for an experienced Group Lead – Clinical GCP QA in Bengaluru. This leadership role is ideal for professionals seeking advanced jobs in Bangalore within clinical research quality assurance, offering exposure to global GCP standards, regulatory compliance, and audit readiness across clinical operations.
Job Details:
- Position Title: Group Leader GCP -QA (Clinical)
- Division: Essential Functions
- Job Level: Thought Leader
- Location: Bengaluru, India
About the Company
Syngene Careers offers exciting clinical job opportunities for professionals across R&D, manufacturing, and analytical services. Syngene is seeking a seasoned professional to lead its Technical Training function, responsible for building and scaling learning programs that strengthen the scientific and technical capabilities of the workforce. This leadership role ensures teams are equipped with the latest skills and knowledge to meet evolving client expectations and regulatory standards, making it one of the most respected employers for jobs in Bangalore.
Qualifications
Education: M.Tech in Basic Medical Sciences
Skills and Capabilities:
- Experience in performing and managing Quality Assurance audits in a GCP environment
- Strong technical knowledge in BE/BA studies, clinical research, drug development, and pharmacology
- Thorough knowledge of regulatory guidelines, including ICH, USFDA, EMA, and MHRA
- Strategic thinking and sound decision-making abilities
Job Description
This Clinical Job at Syngene Careers involves leading GCP Quality Assurance activities for clinical research operations. The Group Lead – Clinical GCP QA will manage audit teams, conduct study-based and process audits, ensure compliance with national and international GCP and GxP regulations, and support inspection readiness. This senior role is ideal for professionals seeking leadership jobs in Bangalore within clinical quality and regulatory compliance.
Key Responsibilities
- Schedule, personally conduct, and manage resources for GCP QA audits supporting clinical operations, including Bioequivalence studies, Clinical Trials (Phase I–III), and Clinical Data Management
- Develop risk-based audit plans focusing on ethical conduct, subject safety, protocol adherence, and GCP requirements
- Provide oversight and participate in audits of clinical activities and review documents submitted to sponsors and regulatory authorities
- Oversee GCP QA auditors, review audit reports, and ensure CAPA plans meet SOPs and regulatory standards
- Collaborate with clinical operations teams for the resolution of audit findings
- Conduct lessons learned debriefs for continuous improvement
- Consult with clinical functions regarding GCP-related vendor performance issues
- Perform onsite or remote vendor audits when required
- Lead or assist investigations of misconduct, serious GCP breaches, and non-compliance
- Escalate critical quality issues to the GCP QA HOD
- Perform or oversee RCA and CAPA processes
- Perform internal process audits, system audits, TMF audits, and 21 CFR Part 11 audits
- Maintain and report GCP QA metrics and quality trends
- Assist management during regulatory inspections
