QMS

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) Job Description explained by (Reporting Manager/Designee) (To be filled Job Description 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.