Job Description

Designation/Position Title: Team Lead GCP QA (Clinical)

Department: GCP Quality, Syngene International Ltd.

Location: Translational Health Science and Technology Institute (THSTI) - Faridabad, Haryana, India.

About Syngene: Syngene is seeking a seasoned professional to manage its GCP quality function at THSTI Faridabad, Haryana on behalf of Syngene GCP Quality Organisation. He/she is responsible for building and scaling Quality Management Systems implementation programs and developing Quality assurance systems and implement QA oversight for clinical First-In Human (FIH) / Phase I studies and related activities. This QA Manager role is pivotal in quality and compliance oversight on clinical operations at the THSTI clinical research facility with the latest skills and knowledge to meet evolving client expectations and national and international regulatory standards and requirements.

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.

Core Purpose of the Role: The GCP QA Sr.Manager-Clinical is responsible for managing the GCP QA audit management and auditors team and to perform the study-based audits, process audits, clinical and safety database audits, and assess the systems and practices for improving the GCP Quality System practices independently and shall consult with GCP Quality Head as required by Syngene International Ltd, Corporate Quality Policies.

This GCP QA Sr.Manager must be comfortable exercising latitude in ensuring the Syngene’ s Translational & Clinical Research (T&CR) MOU collaboration unit at THSTI clinical research facility is compliant with the national and international GCP Quality System, the quality (GxP) regulations and standards it is built on and ultimately is audit /inspection ready to have good outcome.

Comfortable working and communicating professionally with others to reach understanding and agreement as necessary.

Role Accountabilities:

• Schedule, personally conduct and/or manage resources, for GCP QA audits which will enable the clinical (FIH/Phase I/Bioequivalence studies, Clinical data management) operational activities at THSTI clinical research facility to ensure quality and compliance to national and international regulatory requirements.
• Develop risk-based audit plan focusing on ethical conduct, safety & medical care of subjects, adherence to protocols, GCP requirements for clinical (FIH/Phase I/Bioequivalence studies) operations and facility/system audits.
• Provide personal oversight for and /or participate in audits of clinical (FIH/Phase I/Bioequivalence studies, Clinical data management) activities and review clinical, data and documents that will be submitted to sponsors / regulatory authorities.
• Provide oversight of GCP QA auditors to develop specific audit plans, review and assess audit reports to ensure they have met the audit plan and that recommendations and suggested Corrective Action Preventative Action Plans (CAPA) are adequate to ensure compliance with Standard Operating Procedures (SOPs), regulations, and best practices for clinical (FIH/Phase I/Bioequivalence studies), Clinical data management) operations.
• Collaborate with the appropriate clinical (FIH/Phase I/Bioequivalence studies), Clinical data management) operations team in follow-up to external audits to ensure resolution of audit findings in accordance with industry best practices.
• Collaborate with clinical (FIH/Phase I/Bioequivalence studies, Clinical data management) operations in lessons learned debrief to identify the need for continuous improvement and for potential changes to work practices.
• Consult with the concerned Clinical functions (FIH/Phase I/Bioequivalence studies, Clinical data management) regarding perceived GCP related vendor performance issues and when indicated work with them to develop a corrective action plan.
• When indicated/required perform onsite / remote vendor audits and provides follow-up as indicated.
• Provide follow-up corrective action with proposed and contracted vendor services.
• Lead/assist with investigations of misconduct, serious GCP breach and other noncompliance issues.
• Identify and appropriately escalate critical quality issues to GCP QA HOD @ Syngene.
• Perform / Oversee and root cause analysis (RCA) and corrective action preventative action (CAPA)process.
• Perform /Oversee internal process audits, due diligence, system audits, GCP document audits including trial master file (TMF), and 21CFR part 11 audits.
• Periodically maintain and report GCP QA team activity metrics, study quality metrics and trends for assigned program(s) to GCP QA HOD• Assist GCP QA HOD/management in the readiness and hosting of regulatory agency inspections.

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Education: M. Pharm in Pharmacology Or QA / M.Sc. or M. Tech in Basic Medical Sciences/ Life Sciences/Biotechnology.

Skills and Capabilities:

• Performing and managing Quality Assurance audits in GCP environment
• Sound fundamental technical knowledge in BE /BA/ Phase I studies/Clinical research/Drug development/ Basic medical sciences and pharmacology.
• Thorough knowledge in regulatory guidelines (ICH, USFDA, EMA, MHRA,) governing clinical development.
• Strategic thinking and goal oriented with demonstrated good judgment and decision-making experience in a matrix environment

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.