QA Jobs at Syngene | Chemistry Graduates Apply Now
Are you looking for senior QA Jobs and Clinical Jobs with a globally respected research organization? Syngene is hiring a Group Lead – Clinical (GCP QA) in Bengaluru to drive quality excellence across clinical research operations. This leadership role offers an opportunity to shape GCP quality systems, lead high-impact audits, and contribute to regulatory-ready clinical programs within Syngene Careers.
- Location: Bangalore, KA, IN, 560100
- Division: Essential Functions
- Position Title: Group Leader GCP – QA (Clinical)
- Job Level: Thought Leader
About Syngene
Syngene is a global innovation-focused research organization delivering integrated scientific services across discovery, development, and manufacturing. Known for its strong quality culture and regulatory excellence, Syngene Careers offers long-term growth in high-impact QA Jobs and Clinical Jobs within a world-class research ecosystem.
Mandatory expectation for all roles as per Syngene safety guidelines:
- Overall adherence to safe practices and procedures of oneself and the teams is aligned
- Contributing to the development of procedures, practices, and systems that ensure safe operations and compliance with the company’s integrity & quality standards
- Driving a corporate culture that promotes an EHS mindset and operational discipline at the workplace at all times.
- Ensuring the safety of self, teams, and lab/plant by adhering to safety protocols and following environmental, health, and safety (EHS) requirements at all times in the workplace.
- Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team, including self
- Compliance with Syngene’s quality standards at all times
Core Purpose of the Role
The QA Group Leader-Clinical is responsible for managing the GCP QA auditor team and performing study-based audits, process audits, Investigational Site audits, and clinical and safety database audits, and independently assessing systems and practices to improve the GCP Quality System. It shall consult with the GCP Quality Head as required by Syngene International Ltd, Corporate Quality Policies.
This QA Group Lead must be comfortable exercising latitude in ensuring Syngene’s Translational & Clinical Research (T&CR) Services Operating Unit (OU) and its facility are compliant with the national and international GCP Quality System, the quality (GxP) regulations and standards it is built on, and ultimately is audit/inspection ready to have a good outcome.
Comfortable working and communicating professionally with others to reach understanding and agreement as necessary.
Role Accountabilities:
- Schedule, personally conduct, and/or manage resources for GCP QA jobs audits, which will enable the clinical (Bioequivalence studies, Clinical trials (Phase I- III), Clinical data management) operational activities at Translational & Clinical Research (T&CR) operating unit (OU) to ensure quality and compliance with national and international regulatory requirements.
- Develop risk-based audit plan focusing on ethical conduct, safety & medical care of subjects, adherence to protocols, GCP requirements for clinical (Bioequivalence studies, Clinical trials (Phase I- III), Clinical data management) operations, and facility audits.
- Provide personal oversight for and/or participate in audits of clinical (Bioequivalence studies, Clinical trials (Phase I- III), Clinical data management) activities and review clinical data, and documents that will be submitted to sponsors/regulatory authorities.
- Provide oversight of GCP QA auditors to develop specific audit plans, review and assess audit reports to ensure they have met the audit plan and that recommendations and suggested Corrective Action Preventative Action Plans (CAPA) are adequate to ensure compliance with Standard Operating Procedures (SOPs), regulations, and best practices for clinical (Bioequivalence studies, Clinical trials (Phase I- III), Clinical data management) operations.
- Collaborate with the appropriate clinical (Bioequivalence studies, Clinical trials (Phase I- III), Clinical data management) operations team in follow-up to external audits to ensure resolution of audit findings in accordance with industry best practices.
- Collaborate with clinical (Bioequivalence studies, Clinical trials (Phase I- III), Clinical data management) operations in lessons learned debrief to identify the need for continuous improvement and for potential changes to work practices.
- Consult with the relevant Clinical functions (Bioequivalence studies, Clinical trials (Phase I-III), Clinical data management) regarding perceived GCP-related vendor performance issues, and, when indicated, work with them to develop a corrective action plan.
- When indicated/required, perform onsite/remote vendor audits and provide follow-up as indicated.
- Provide follow-up corrective action with proposed and contracted vendor services.
- Lead/assist with investigations of misconduct, serious GCP breaches, and other noncompliance issues.
- Identify and appropriately escalate critical quality issues to the GCP QA HOD.
- Perform/Oversee and root cause analysis (RCA) and corrective action, preventative action (CAPA) process.
- Perform/Oversee internal process audits, due diligence, system audits, GCP document audits, including trial master file (TMF), and 21CFR part 11 audits.
- Periodically maintain and report GCP QA team activity metrics, study quality metrics, and trends for assigned program(s) to GCP QA HOD.
- Assist GCP QA HOD/management in the readiness and hosting of regulatory agency inspections.
Syngene Values
- Excellence
- Integrity
- Professionalism
Education
M.Sc/M. Pharm/M. Tech in Basic Medical Sciences/Life Sciences/Biotechnology.
Skills and Capabilities:
- Performing and managing Quality Assurance audits in the GCP environment
- Sound fundamental technical knowledge in BE/BA studies/Clinical research/Drug development/Basic medical sciences, and pharmacology.
- Thorough knowledge of regulatory guidelines (ICH, USFDA, EMA, MHRA) governing clinical development.
- Strategic thinking and goal-oriented, with demonstrated good judgment and decision-making experience in a matrix environment.
