Job Title: Clinical Trial Management - QA
Job Location: Bangalore
About Syngene : Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.
Mandatory expectation for all roles as per Syngene safety guidelines
- Overall adherence to safe practices and procedures of oneself and the teams aligned
- Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards
- Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
- Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, 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 to Syngene s quality standards at all times
- Hold self and their teams accountable for the achievement of safety goals
- Govern and Review safety metrics from time to time
Core Purpose of the Role:
- 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.
Role Accountabilities: Accountable for the above-assigned role
Leadership Capabilities: Must have good communication skills to interact with stakeholders
Syngene Values
All employees will consistently demonstrate alignment with our core values
- Excellence
- Integrity
- Professionalism
Specific requirements for this role
Experience: 5-8 years
Skills and Capabilities: 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
Education: B. Pharm/M. Pharm / M.Sc. / Any Graduate
Equal Opportunity Employer
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