Syngene Hiring Seasoned GCP Quality Senior Manager/Auditor for THSTI Faridabad Facility

Position Overview Syngene International Ltd. is inviting applications from senior quality professionals for the position of GCP Quality Auditor (Clinical), also referred to as GCP QA Sr. Manager–Clinical, based at the Translational Health Science and Technology Institute (THSTI) in Faridabad, Haryana. This critical role involves managing Syngene’s GCP quality function, building and scaling Quality Management Systems (QMS), and providing comprehensive Quality Assurance (QA) oversight for clinical operations, including First-In-Human (FIH) / Phase I studies and related activities.

Position Details

Eligibility Criteria

• Academic Background: M.Pharm in Pharmacology or QA, or M.Sc. / M.Tech in Basic Medical Sciences, Life Sciences, or Biotechnology.
• Core Competencies & Skills:
  • Demonstrated expertise in performing and managing comprehensive Quality Assurance audits within a Good Clinical Practice (GCP) environment.
  • Robust technical knowledge spanning Bioequivalence (BE)/Bioavailability (BA) studies, Phase I/FIH trials, overall clinical research, and basic medical sciences/pharmacology.
  • In-depth understanding of global regulatory guidelines governing clinical development (ICH, USFDA, EMA, MHRA, and national standards).
  • Strategic thinking, exceptional judgment, and decisive leadership experience within a matrix organizational structure.

Key Responsibilities

• QMS Implementation: Build, implement, and scale the implementation programs for Quality Management Systems, QA assurance systems, and QA oversight specifically for high-stakes clinical First-In-Human (FIH) / Phase I studies.
• Compliance Oversight: Provide robust quality and compliance oversight for clinical operations at the THSTI research facility, ensuring adherence to national and international regulatory standards and guidelines (ICH-GCP, GxP).
• Audit Management: Manage the entire GCP QA audit management process and team of auditors; perform study-based audits, process audits, clinical database audits, and assess systems and practices to improve the overall GCP Quality System independently. Consult with the GCP Quality Head as required by Syngene’s Corporate Quality Policies.
• Audit Planning & Execution:
  • Schedule, personally conduct, and manage resources for GCP QA audits, ensuring clinical (FIH/Phase I/BE studies, Clinical data management) activities meet sponsors’ and regulatory requirements.
  • Develop a risk-based audit plan prioritizing ethical conduct, subject safety and medical care, protocol adherence, and GCP requirements.
• Corrective Action (CAPA): Perform/Oversee the Root Cause Analysis (RCA) and Corrective Action Preventative Action (CAPA) process. Review and assess audit reports to ensure recommendations and suggested CAPA plans are adequate to ensure compliance with SOPs and regulations.
• Inspection Readiness: Ensure the Syngene-THSTI Unit is audit/inspection ready; assist the GCP QA HOD/management in regulatory agency inspections. Escalating critical quality issues to the HOD when necessary.
• Metrics Reporting: Periodically maintain and report GCP QA team activity metrics, study quality metrics, and trends to the GCP QA HOD.

Application and Submission Guidelines

• Application Deadline: Interested candidates must submit their online applications directly through the Syngene career portal on or before September 23, 2026.
• Mode of Submission: Use the official link [APPLY for GCP QA Auditor (Clinical) >>] (link is representative of the actual online portal) to complete the submission process. Ensure all professional and academic documents are updated for verification.

About the Author

Pharm'Up

Author

An E-platform for Pharma Learners

View All Posts