Assitant Manager
Biocon Sdn Bhd
مجموع سنوات الخبرة :13 years, 6 أشهر
• Qualified Lead Auditor - Participated in the internal auditing program to strengthen the QMS system and system improvement across the worksite.
• Actively participated in international Regulatory audits e.g. MHRA-UK, USFDA, HEALTH CANADA, NPRA Malaysia, MOH (UAE, KSA, Oman, Qatar, and Mexico) ANVISA Brazil, etc.
• Quality Management system (QMS): Investigation of non-conformances by spot check, using investigation tools like 5WHY, Fishbone analysis, Cause, and Effect diagram, etc.
• Initiation of Corrective and Preventive Action, follow up for implementation and effectiveness Check.
• Change Control initiation, review follow up for approval and implementation - trending and further documentation.
• Document Design (protocols, reports, procedures, and Batch Manufacturing Records for cGMP operations) as per ALCOA+ requirement.
• Well verse in ERP and Quality Management software like SAP, Trackwise.
• Training and coaching to team members for creating awareness and develop competence through pieces of training.
• Human factor program and Human error reduction program SME (Subject Matter Expert)
• Achieved ‘The Bio Contribute Award’ for contribution in Process and Cleaning Validation of Insulin Glargine Drug Substance to complete project Right First Time.
• Actively involved in implementation of Digitization initiative (SAP SF System for training, LIMS for Quality Laboratory, Monitoring Manager and Trackwise for QMS handling).
• Responsible Shift in charge of Scale Up batches, Consistency, and Process Validation Batches (handled team of 8 members for Shift operations).
• Sterility Evaluation of Feed tanks and fermentors: Designing Protocols for sterility evaluation, conducting training, and executing sterility evaluation.
• Sterilization in Place SIP (Empty / Media) Cycles and Cleaning in Place Cycle CIP (for 5000Litre and 50000 Litre fermentors).
• Actively involved in successful Commissioning and Qualification of Drug Substance Facility Right First time.
• Actively involved in Qualification (Installation, Operation, and Performance) of Fermenters, automation system, and other process ancillary vessels.
• Completed Qualification and Temperature mapping studies of Incubator shakers, Ultra-low Temperature Freezers, and incubators.
• Maintenance of recombinant Pichia pastoris cell banks for Insulin and Insulin Analogues.
• Responsible Shift in charge of Scale Up batches, Consistency, and Process Validation Batches (handled team of 8 members for Shift operations).
• Sterility Evaluation of Feed tanks and fermentors: Designing Protocols for sterility evaluation, conducting training, and executing sterility evaluation.
• Sterilization in Place SIP (Empty / Media) Cycles and Cleaning in Place Cycle CIP (for 5000Litre and 50000 Litre fermentors).
• Actively involved in preparation Batch Manufacturing records, Process and Cleaning validation protocols and reports.
• Execution of laboratory-scale cell culture Fed-batch fermentation for Insulin and Insulin Analogues manufacturing
• Inoculum development, Fermentation of Lactobacillus strains (Bacterial) as per Fed-Batch fermentation and recording in Batch Manufacturing Record.
• Centrifugation of incubated broth in open bowl type centrifuge and Lyophilisation of bacterial slurry in Lyophilizer.
• Blending of lyophilized powder with filler and powder filling in Capsules, packaging (OSD forms manufacturing).
• Validation of Autoclave, Refrigerators, deep freezer, incubator
• Preparation of Procedure, protocol, recording and formats as per cGMP norms and executed Documents review of Quality records.
• Training to subordinates and teammates on cGMP topic and required procedures.
Masters project was - Utilization of Baggase (Sugar manufacturing by product) for production of Celulase by Solid state Fermentation.