Aqa Reviewer

JOB DESCRIPTION Designation AQA Reviewer Job Location Bangalore Department Analytical Quality Assurance About Syngene Incorporated in 1993 Syngene International Ltd is an innovation-focused global discovery development and manufacturing organization providing integrated scientific services to the pharmaceutical biotechnology nutrition animal health consumer goods and specialty chemical industries around the world Syngene s clientele includes world leaders such as Bristol-Myers Squibb Baxter Amgen GSK Merck KGaA and Herbalife Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems improve R D productivity speed up time to market and lower the cost of innovation 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 Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Job Purpose To review the data reports generated from GMP Laboratory Stability and to monitor the GMP Lab compliance Key responsibilities 1 Online Sequence Document review in HPLC GC KF PXRD ICPMS LCMS other all analytical instruments CD FC - Intermediate FP Stability 2 Offline Raw Data review in ELN CD FC - IPQC Intermediate FP Stability and release of IPQC TI sheets in 24 7 3 Daily verification data review PM reports and Lamp intensity report review in ELN 4 Compiled Report review CD FC - IPQC Intermediate FP Stability 5 Calibration sequence data review of HPLC S17 and release of instrument Raw material data review and release in LIMS SAP 6 Reconciliation of EDMS issued prints formats 7 Audit trial review of Standalone systems and chromeleon application 8 Monthly Date Time verification of approximately 20 standalone instruments 9 Review of analytical raw data generated by analyst protocols reports pertaining to the section as per the standard operating procedure and specification 10 Ensuring verifying and reviewing the instrument usage log periodically and accordingly checking the labels as per SOP 11 Review of Outsourced analytical report 12 Review of logbooks with respect to all activity performed in the lab 13 Responsible for taking any other job allocated by Department Head Department In charge 14 Review of technical data in analytical document viz Calculations Chromatograms method parameters integration logbook entries WS RS and Column usage records method parameters reconciliation vendor COA and other technical data in analytical document 15 Reviewer shall ensure the documents physically for availability of all the pages of ODS and supporting documents 16 Review the documents for completeness compliance to Good documentation practices test results against specification limits or acceptance criteria as mentioned in protocol and reconciliation of forms issued as applicable 17 In case of any discrepancy immediately notify to the reporting manager or his designee or Head or designee GMP Analytical Laboratory 18 Ensuring of conducting regular GMP rounds at Quality Control Laboratory Educational Qualification M Sc Chemistry or Analytical or equivalent Technical functional Skills The candidate should possess good communication leadership and technical skills in Laboratory instruments like HPLC GC GCMS LCMS PXRD KF etc He she should have working knowledge in quality conducting investigations and quality management systems He she should have experience in review of data generated from QC team of QA professional Experience 4 to 8 years 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