Qms [07/10/2025]

4 weeks ago

Bangalore Karnataka, India Syngene International Full time

Lead and or participate in regular facility walkthroughs for Biopharmaceutical Operations to adherence to all time audit readiness and compliance with regulatory requirements including Data Integrity assessment Specimen Signature entry Verified by Department Training Coordinator To be filled manually explained by Reporting Manager Designee To be filled accepted by Employee To be filled manually Lead and or participate in timely reporting of deviations appropriate investigations to identify root cause or most probable root cause and proposal implementation of appropriate CAPA to prevent re occurrence Lead and or participate in appropriate manufacturing investigations for OOS results and Customer Complaints to identify root cause or most probable root cause and proposal implementation of appropriate CAPA to prevent re occurrence Lead formal proposal of CAPA for facility walkthrough finding outcome through the Track Wise system facilitate timely acceptance review approval for implementation by the respective stakeholders Lead and or participate implementation of approved CAPA Change Control for Biopharmaceutical Operations Verify the Operational and Compliance Metrics for Biopharmaceutical Operations and reporting the same to management Ensure timely receiving tracking and providing response for the IPQA observation for Biopharmaceutical Operations and its closure Ensure timely proposal appropriate impact assessment and implementation of Change Controls Approve NVPC trend report Environmental Monitoring Data for Biopharmaceutical Operations Impart and or support training on SOPs protocols and On-the-Job activities Ensure Risk Management for Biologics Operations covers following elements and ensure proposal and implementation of appropriate risk mitigation actions CAPA o Quality and Compliance Risks o Operational Risks o Data Integrity Risks Support for timely preparation review and approval of GMP documentations for Biologics Operations o Standard Operating Procedures EOP IOP and SOP o Protocols and Reports o Batch Manufacturing Records o Any other GMP relevant documentation Implement Operational Excellence initiatives for Biologics Operations

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