QA Auditor- CTM

JOB DESCRIPTION

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.

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

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

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.