Group Lead

Job Title Group Leader -GCP QA Clinical JOB DESCRIPTION Job Title Group Leader GCP -QA Clinical 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 Core Purpose of the Role The QA Group Leader-Clinical is responsible for managing the GCP QA auditors team and to performing the study-based audits process audits Investigational Site 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 QA Group Lead must be comfortable exercising latitude in ensuring the Syngene s Translational Clinical Research T CR Services Operating Unit OU and its 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 Bioequivalence studies Clinical trials Phase I- III Clinical data management operational activities at Translational Clinical Research T CR operating unit OU 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 Bioequivalence studies Clinical trials Phase I- III Clinical data management operations and facility audits Provide personal oversight for and or participate in audits of clinical Bioequivalence studies Clinical trials Phase I- III 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 Bioequivalence studies Clinical trials Phase I- III Clinical data management operations Collaborate with the appropriate clinical Bioequivalence studies Clinical trials Phase I- III 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 Bioequivalence studies Clinical trials Phase I- III 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 Bioequivalence studies Clinical trials Phase I- III 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 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 HODo 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 Specific requirements for this role 1 Experience 15 to 20 Years of relevant technical managerial and leadership experience in Clinical Research Industry 2 Education M Sc M Pharm M Tech in Basic Medical Sciences Life Sciences Biotechnology Skills and Capabilities Performing and managing Quality Assurance audits in GCP environment and with at least 10 years in team managing leading capacity Sound fundamental technical knowledge in BE BA 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