DEVIATION MANAGEMENT AND MANUFACTURING INVESTIGATI

Role Accountabilities: Timely reporting of deviations and perform appropriate investigations to identify root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence. Perform 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 reoccurrence. Participate in the audits as SME for OOS investigations and manufacturing investigations. Timely tracking of Operational and Compliance Metrics for Manufacturing Operations and management reporting. Ensure Risk Management for Biologics Operations covering following elements and ensure proposal and implementation of appropriate risk mitigation actions (CAPA) Perform and support timely preparation, review and approval of GMP documentations. Conduct and/or support training on SOPs, protocols and On-the-Job activities. Timely proposal and implementation of appropriate CAPA for audit findings.