Contributed 14 years in production of pharmaceutical API (Bulk Drug) with strong understanding of consumption norms of raw ingredients.
• Handled finished goods powder processing maintaining the required atmosphere - positive pressure, humidity control, temperature control etc according to cGMP specifications.
• Co-ordinated with quality control deptt, QA deptt, planning deptt & warehouse deptt. to ensure adherence to quality parameters & reviewing of batch production records.
• Maintained appropriate various FDA documentation- Blending record, FG transfer record, quality data record, PP-rooms cleaning record, AHU records etc.
• Regularly achieved production milestones with strong commitment to work assignments.
• Encouraged seamless communications amongst team members and generated excellent work harmony for better efficiency.
• Documentation Qualification: Installation Qualification, Operational Qualification, Performance Qualification of equipments like Reactor- SS & MSGL both, Rotary Vacuum Dryer, Sparkler Filter, Tray Dryer, Vacuum Tray Dryer, Agitated Nutsche Filter etc protocol & report preparations and exhibit batch protocols.
• Documentation Validations: Process performance qualification, Drying process validation, Blending time validation, Prospective process validation, Concurrent process validations: Protocol & reports preparations.
• Handled FDA audits USA, TGA audits Australia, WHO Health organization audits, EU audits, CQA audits, MCA UK audits.
• Develop, implement and maintain procedures to ensure that products are produced within specification: Change controls implementations & closures in TRACKWISE software.
• Assist in ensuring Product Integrity and Traceability processes are robust, reviewed and maintained. Ensuring that all product specifications are aligned with process capabilities.
• Process Control: controlling critical process parameter to achieve better yield and quality.
• Strong Chemical Process handling working with strong commitment with very high caliber.
• Strong grasp of Knowledge of in-process testing like pH checking, Determining Moisture content handling instrument make of METROHM , Strength of HCl, NH3, NaOH etc
• Strong grasp of making Investigation Report if the batch is failure & CAPA Investigations.
• Maintain ISO documents like environment management system, aspect & impact evaluation etc.
• Making Deviation Report on the basis of FDA guidelines. Whether the deviation is planned or unplanned.
• Raw Material procurement and reconciliation with stock in SAP system.
• Downloading the data from SAP system having strong grasp knowledge of using SAP system with very high caliber.
• Excellent planning, organizational and project management skills.
• Creative, energetic and willing to implement new ideas.
• Demonstrated positive trends in key quality management process measures (rework, deviations, complaint, CAPA management) – Expert in operating Track wise software.
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