Qa Auditor- Clinical

Job Title QA Auditor- 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 To perform the role as Clinical QA auditor to verify compliance to ICH-GCP NDCT Rule and other applicable regulatory requirements with respect to BABE Phase I studies Comfortable working and communicating professionally with others to reach understanding and agreement as necessary Other Responsibilities To perform or assist any other relevant job with relevant training as and when required by Department Head or Management Role Accountabilities To perform study specific in-process audits as per audit plan to ensure that study is conducted in compliance with in-house SOPs protocol and applicable regulatory guidelines etc To perform study specific retrospective audits of informed consent document study files like TMF case report forms raw data forms draft clinical study report and other applicable documents to ensure that study is conducted in compliance with in-house SOPs protocol and applicable regulatory guidelines etc To perform database audits in EDC application for applicable studies To prepare and issue audit reports to respective operations team in consultation with Manager Department Head and follow-up the implementation of CAPA to ensure timely closure of audit observations To initiate change control and follow-up for the same for timely closure in consultation with Manager Department Head To review change control deviation and other QMS elements taken by operations team and follow-up for its timely closure To review draft documents like Protocol ICD CRF etc before its finalization To assist for system audit as co-auditor and or providing input to Compliance QA team if required To perform vendor audit as lead co-auditor as per vendor audit forecast plan if required To review qualification and validation documents if required by Manager Department Head To assist and or participate whenever required as per Department Head discretion during system audit internal and external audits and inspection as part of audit inspection readiness To assist in preparation or reviewing the CAPA whenever required during system audit internal and external audits and inspection To ensure QA records generated are archived on periodic basis To assist Manager Department Head whenever required to collate quality systems data for trending the Quality metrics To escalate immediately to Manager Department Head in case of any serious non-compliance to protocol and ALCOA principles Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role 1 Experience 6 - 9 years 2 Demonstrated Capability Auditing skills Understanding of regulations Attention to detail 3 Education M Sc in Life Sciences or M Pharm 4 Sound technical Knowledge in ICH GCP NDCT Rule and other applicable guidelines 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 accom