Successfully executed Enhancement Capex Projects; Capex Budget Estimation, CAPEX & OPEX Items Procurement, FAT of Equipment, SAT of Equipment, Installation, Commissioning & Qualification Manufacturing and Packing Automation, F&D Lab and QC Lab Instruments and Equipment negotiation & ProcurementContributed towards:Expansion projects URS preparation and Techno-commercial offer from vendorsBudget preparation with different options for Greenfield projects as well as… Show more Successfully executed Enhancement Capex Projects; Capex Budget Estimation, CAPEX & OPEX Items Procurement, FAT of Equipment, SAT of Equipment, Installation, Commissioning & Qualification Manufacturing and Packing Automation, F&D Lab and QC Lab Instruments and Equipment negotiation & ProcurementContributed towards:Expansion projects URS preparation and Techno-commercial offer from vendorsBudget preparation with different options for Greenfield projects as well as Brownfield projects for sterile injectable manufacturing facilityParticipated in LISP 3 days’ workshop for collaboration & smooth transition among Leadership team Show less

Accomplished Brownfield Project of Glass Ampoule Line, Vial Lyophilize Combi Line and Packing Automation start from conceptualization to operational including Capex Budget preparation, Cash flow planning & management with Finance, Project management & Timely completion of projects within Approved budgetSuccessfully spearheaded Techno-Commercial offer receiving from different Equipment suppliers / Vendors, Technical comparison & price Negotiation, Procurement from Purchase Order to… Show more Accomplished Brownfield Project of Glass Ampoule Line, Vial Lyophilize Combi Line and Packing Automation start from conceptualization to operational including Capex Budget preparation, Cash flow planning & management with Finance, Project management & Timely completion of projects within Approved budgetSuccessfully spearheaded Techno-Commercial offer receiving from different Equipment suppliers / Vendors, Technical comparison & price Negotiation, Procurement from Purchase Order to timely delivery at site also ensured timely Installation & Commissioning, Qualification to handoverProjects Accomplished:Glass Ampoule Filling Line Vial & Lyophilize Combi Line Clean Room Designing, HVAC Designing WFI/ DRO/ PSG Technology Selection & Procurement, Installation & OperationalEnhancement of WFI Loop system RedesigningManufacturing process automation of Parenteral Fat Emulsion Product (Propofol) with 21 CFR compliantAutomation project of CIP (Cleaning-In-Place) & SIP (Steaming-In-Place)Enhancement of QA & QC Laboratory with Sterile Microbiology Testing Facility and QA/QC Equipment, Instruments procurement. Automation Projects: Auto Inspection Camera based Technology from Europe for Liquid Vial & Ampoule with 21 CFR compliant Auto Like Detection Technology High Voltage Pin Hole detector from China for Liquid Vial, Ampoule & IV Bag Automatic Thermoforming Blister Packing for Vial, Ampoule & IV Bag from Europe Automatic Cartoning from Europe for Vial & AmpouleImplemented Continuous Particle Monitoring System for Particle monitoring in Sterile Filling Area to meet the USFDA requirement Show less

Projects Accomplished:Sterile Facility Expansion & Upgradation Projects as per Regulatory standard with addition of 3 IV Lines within Targeted TimelineBrownfield Projects of Aseptically Field Injectables Lines Project within Targeted TimelineManufacturing & Packing Automation ProjectsAdministered:Redesigning of Clean Rooms, HVAC, WFI/ DRO/ PSG & ProcurementRedesigning of WFI Loop system, Packing area & Packing LinesRedesigning of QA-QC… Show more Projects Accomplished:Sterile Facility Expansion & Upgradation Projects as per Regulatory standard with addition of 3 IV Lines within Targeted TimelineBrownfield Projects of Aseptically Field Injectables Lines Project within Targeted TimelineManufacturing & Packing Automation ProjectsAdministered:Redesigning of Clean Rooms, HVAC, WFI/ DRO/ PSG & ProcurementRedesigning of WFI Loop system, Packing area & Packing LinesRedesigning of QA-QC Facility, Stability Lab Facility, RM/PM, FG Stores Redesigning of Change Room & Entry-Exit LayoutImplemented Raw Material Weighing & Printing system in Dispensing to eliminate manual data filling in BMR and established printed evidence Show less

Worked as a Plant Head of Injectable FacilityStreamlined the manufacturing facility as per the Lean concept and implemented management tools in practice like Kaizen, CEDAC, 5 WHY & 1H, FIFO System, JIT, and so onIncreased productivity and product quality by continuous feedback to the manufacturing operator and chemistEstablished online documentation filling process

Part of strategic team - Corporate Technical Department at HOFormulated project report for various Greenfield manufacturing facility for future expansion like Bag lines, IV Fluid manufacturing Lines, Glass Vial / Ampoule Lines, Lyophilized product lines, Fat Emulsion - Propofol LinesDirected product technology transfer starting from HO-F&D to Plant exhibit batches with RM / PM procurement & all logistical functionsAssisted: Manufacturing Team for new technology sourcing,… Show more Part of strategic team - Corporate Technical Department at HOFormulated project report for various Greenfield manufacturing facility for future expansion like Bag lines, IV Fluid manufacturing Lines, Glass Vial / Ampoule Lines, Lyophilized product lines, Fat Emulsion - Propofol LinesDirected product technology transfer starting from HO-F&D to Plant exhibit batches with RM / PM procurement & all logistical functionsAssisted: Manufacturing Team for new technology sourcing, enhancement related to Regulatory requirement in existing facility, BMS - System for HVAC conceptualization to operational for clean room and Marketing Team with technical details for development and execution of marketing strategies Show less

Delivered the role of Plant Head for Aseptically Filed Sterile powder injectable plant & Greenfield Project designed for US & Europe marketCo-ordinated for Facility Designed with Architect, Structural engineering, MEP, HVAC consultants and Civil contractor and Layout approval from Management and drove Project execution activitiesDevised URS with QA Team for process equipment, utility equipment with capacity calculations & Technical specificationsPerformed FAT at Vendor's… Show more Delivered the role of Plant Head for Aseptically Filed Sterile powder injectable plant & Greenfield Project designed for US & Europe marketCo-ordinated for Facility Designed with Architect, Structural engineering, MEP, HVAC consultants and Civil contractor and Layout approval from Management and drove Project execution activitiesDevised URS with QA Team for process equipment, utility equipment with capacity calculations & Technical specificationsPerformed FAT at Vendor's sites in Europe and India, and ensured timely delivery of finalized equipment at site, Installation and Qualification within Timeline & Budget, getting the facility operational as DesignedLead Designing of Clean Rooms, Water system with loop, Clean utilities like SRO, DRO, Nitrogen, PSG, and so onImparted Trainings to teams on Clean Room Entry-Exit for Aseptically field Products, Manufacturing, Packing, Material management, Online documentationAddressed: Plant Approval Committee Local FDCA for Plant Layout approval as Technical Person as well as Regulatory Inspections, WHO-GMP, MHRA, ANVISA, and ANVIMA for facility approval Show less

Worked as a Production Manager with Plant Operation, Purchase & PPA for IV Fluid FacilityWas responsible for Purchase of Raw Materials, Primary Packing Materials, Secondary Packing Materials, Boiler Fuels etc. along with Production Planning and Availability (PPA)Follow Just-In-Time to control Inventory and wastageWas responsible for Plant Wearhouse & Dispatch managementWas responsible for Purchase Cost and Cashflow management was responsible for Planning… Show more Worked as a Production Manager with Plant Operation, Purchase & PPA for IV Fluid FacilityWas responsible for Purchase of Raw Materials, Primary Packing Materials, Secondary Packing Materials, Boiler Fuels etc. along with Production Planning and Availability (PPA)Follow Just-In-Time to control Inventory and wastageWas responsible for Plant Wearhouse & Dispatch managementWas responsible for Purchase Cost and Cashflow management was responsible for Planning & Achieving Production Plan as per the Marketing requirement, by ensuring ZERO stock out of the SKU at market placewas responsible for entire Manufacturing operations of 3 LVP Production Line manufacturing from 100 ml to 1000 ml in Plastic bottles and 1 SVP Production Line manufacturing from 2 ml to 10 ml in Plastic Ampoule, all the Packing Lines, RM/PM Store, FG/GQ Store, FG/QG & dispatch with Production Planning & Availability (PPA) of Two Units Show less

Responsible for Production of 4 IV Fluid manufacturing lines, 8 Packing Lines, StoresDesigned packing line to pack daily production in same day, with cost control to achieve maximum productivityEstablished daily productivity feedback mechanism with shift in-charges, shift chemists, machine operators and packing chemists with ownership cultureImplemented management tools in practice like Kaizen, 5WHY analysis, CEDAC, OEE