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Group Leader

4 weeks ago

Bengaluru, Karnataka, India Syngene Full time

Job Title: Group Leader

Job Summary:

As a Group Leader at Syngene, you will be responsible for managing the GCP QA auditors team and performing study-based audits, vendor audits, and assessing systems and practices for improving the GCP Quality System. You will work closely with the GCP Quality Head to ensure compliance with Syngene International Ltd, Corporate Quality Policies.

Key Responsibilities:

  • Schedule, conduct, and manage resources for GCP QA audits to ensure quality and compliance to national and international regulatory requirements.
  • Develop risk-based audit plans focusing on ethical conduct, medical care of subjects, adherence to protocols, GCP requirements for BE /BA/Phase I operations, and facility audits.
  • Provide personal oversight for and/or participate in audits of BE /BA/phase I activities and review clinical, bioanalytical, pharmacokinetic/statistical data and documents submitted to sponsors/regulatory authorities.
  • Collaborate with the operations team to ensure resolution of audit findings in accordance with industry best practices.
  • Consult with operations regarding perceived GCP-related vendor performance issues and develop corrective action plans when necessary.

Requirements:

  • 15 to 20 years of relevant technical, managerial, and leadership experience in Clinical Research Industry.
  • M.Sc./M. Pharm/M. Tech in Basic Medical Sciences/Life Sciences/Biotechnology.
  • Sound fundamental technical knowledge in BE /BA studies/Clinical research/Drug development/Basic medical sciences and pharmacology.
  • Thorough knowledge in regulatory guidelines (ICH, USFDA, EMA, MHRA) governing clinical development.

Equal Opportunity Employer:

Syngene is an equal opportunity employer and provides reasonable accommodations for qualified individuals with disabilities.