Syngene Hiring QA Auditor - M.Pharm, B.Pharm, MSc Apply

Syngene is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit.

Post : QA Auditor - CTM

Job Description
• Ensure that all clinical trial processes, systems, and documentation are compliant with regulatory requirements and industry standards.
• Support clinical trial teams by identifying potential risks and implementing appropriate CAPA.
• Perform QA audits internally and at investigator sites of clinical trial data & records to assure compliance with SOPs, study protocols. Good Clinical Practice Guidelines and relevant regulations.
• Collect and review responses to audit observations and follow-up / escalate inadequate or delayed responses as necessary to ensure timelines are met and responses of satisfactory quality are obtained.
• Collaborate with the appropriate CTM Operations team members in follow-up to the clinical site audits to ensure resolution of audit findings with the appropriate CAPA in accordance with GCP and other applicable regulatory requirements and relevant best GxP practices.
• Effectively plan & collaborate (Co-Audit) with Compliance QA team to conduct scheduled & unscheduled QA system audits to ensure that clinical trials monitored & managed by Syngene are of the Highest standards and are in compliance with the requirements of SOPs, Study protocols, relevant regulations & guideline
• Maintain the highest standards of data integrity, process efficiency, and adherence to SOPs and best practices.
• Oversee quality control of trial operations, contributing to the overall success of clinical trials in alignment with timelines, budgets, and regulatory guidelines.
• Maintain required Syngene QA tools and ensure Syngene QA systems are regularly updated with accurate information for audits and other activities.
• Facilitate clinical trial sponsor audits as assigned in collaboration with compliance QA team.
• Facilitate clinical trial regulatory inspections (at investigational sites) as assigned in collaboration with Sponsor representative.
• Perform and deliver high quality audits /audit reports within specified timelines / budgets, with oversight on junior auditors.
• Participate in co-audits / observed audits with client representatives or other QA auditors when required.
• Travel nationally/ internationally for audits as required.
• Foster collaboration between cross-functional teams, including clinical operations, data management, and regulatory affairs, to ensure smooth and compliant trial execution.

Candidate Profile
Highly detail-oriented and good communication skills. The ideal candidate should have a deep understanding of clinical trial processes, strong proficiency in Clinical Trial Management Systems (CTMS), MS-office and Electronic Data Capture (EDC) tools, and a solid grasp of regulatory compliance standards (GxP, ICH-GCP, etc.). Prior experience in handling oncology trials is preferred. Should be willing to travel across the sites for QA Audits

Additional Information
Experience : 5-8 years
Qualification : B.Pharm, M.Pharm, M.Sc, Any Graduate
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : QA
End Date : 31st August 2025