JOB DESCRIPTION Job Title: QA Auditor – Central Laboratory Job Location: Bangalore Job Level: Foundational About Syngene : Syngene (<a href="http://www.syngeneintl.com">www.syngeneintl.com</a>) 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 <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:105%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Overall adherence to safe practices and procedures of oneself and the teams aligned</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:105%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:105%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Driving a corporate culture that promotes environment, health, and safety (EHSS) mindset and operational discipline at the workplace at all times.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:105%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Ensuring safety of self, teams and lab by adhering to safety protocols and following environment, health, and safety (EEHS) requirements at all times in the workplace.</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:105%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">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</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:105%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Compliance to Syngene’ s quality standards at all times</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;line-height:105%;font-size:11.0pt;font-family:'Calibri Light', sans-serif;color:#262626">Hold self accountable for the achievement of safety goals </li> </ul> Core Purpose of the Role: Support the implementation and maintenance of the laboratory quality management system to ensure accurate, reliable, and compliant diagnostic testing. <ul style="margin-bottom:0.0cm;margin-top:8.0px"> <li style="text-align:justify;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Responsible for the QMS of Department related to Central Laboratory – viz. NABL requirements - ISO 15189:2022: Medical Laboratories –requirements for quality and competence; NABL guidance documents and CAP requirements and other support departments of Syngene Clinical Development.</li> <li style="text-align:justify;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Record control – ensure that all records are written legible. Control and maintain records in the QA department.</li> <li style="text-align:justify;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Audit Management: Plan (including preparation of relevant audit related documents, review of documents) and perform relevant audits: study-based audits, quality system audits (based on CAP and NABL), process audits, vendor audits. Ensure corrective and preventive action plan generated and follow-up on the closure of the same. Alternatively, follow-up audits can be done. </li> <li style="text-align:justify;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Qualification and validation: Review of qualification and validation documents.</li> <li style="text-align:justify;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">To conduct audits for the following vendors: Biomedical waste management, couriers, third party archival, calibration agencies, laboratory reagent suppliers; software and instrument vendors. </li> <li style="text-align:justify;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">To conduct system audits for the following departments: Central Laboratory, Maintenance, IT. </li> <li style="text-align:justify;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Review relevant documents (qualification and validation documents) pertaining to the Computerized system. Audit relevant computerized system during study audits and system audits.</li> <li style="text-align:justify;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Review of Proficiency Testing (PT), Inter Laboratory comparison results, quality indicators for outliers. </li> <li style="text-align:justify;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Accreditation: Responsible for liaising with accreditation authorities– viz. College of American Pathologists (CAP); and National Accreditation Body for Testing and Calibration Laboratories (NABL). Review of relevant requirements / documents.</li> <li style="text-align:justify;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Analyze the root-cause for non-compliance / deviations; analyze trends observed (if any) and advice on resolving issues. </li> <li style="text-align:justify;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Standard Operating Procedures’ (SOPs’): Preparation and revision of SOPs’ relevant to their area; review of SOPs from relevant departments; issue of SOPs’, forms and logbooks to relevant departments; </li> <li style="text-align:justify;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold"> Review of relevant documents (other than SOPs’) generated – viz. protocol, testing procedures, study plan, clinical study report; and so on.</li> <li style="text-align:justify;margin:6.0pt 0.0cm 6.0pt 0.0px;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Regulatory inspections and sponsor audit: Participate in Regulatory inspections and sponsor audit by preparing– liaising with the relevant department for the preparation; review documents, conduct mock-audits, guide personnel. Interact with Regulatory inspectors – accompany and answer queries during the audit. Prepare and review corrective and preventive action plan and follow-up on the implementation of the same. </li> </ul> Syngene Values All employees will consistently demonstrate alignment with our core values <ul style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold"> Excellence</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold"> Integrity</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold"> Professionalism</li> </ul> Specific requirements for this role <ol style="margin-top:0.0cm;margin-bottom:0.0cm"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Demonstrated Capability- Knowledge on ISO 15189:2022 and CAP requirements</li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;text-align:justify;font-size:10.0pt;font-family:Calibri, sans-serif;color:#262626;font-weight:bold">Education- M.Sc. (science, biotechnology)</li> </ol> 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.

QA Auditor - Central Laboratory (Bangalore, KA, IN, 560100) @ syngeneinternational

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