Viralkumar Modi

Experience

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  Rajat Pharmachem Ltd

  Jul 2012 - Feb 2013

  Formulation Development and process transfer Officer

  • Development of new products for commercial market,• Plan, execute scale up and commercial batches for launch in ROW market,• Ensure timely availability and release of Raw material and Packaging Material,• Execute investigation and draft report on the failure batches, deviations,• Draft and review of Master batch records and Master Packaging record, • Draft and review of Specification, STP, SOP,• Monitor commercial production and packaging of Tablet, Capsule,• Process Improvement and optimization,• Draft SOP related to Production, Packaging and QA,• Shift scheduling and allocation of manpower in manufacturing & packaging, Show less

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  Euphoric pharmaceutical

  Mar 2013 - Aug 2013

  Executive, RnD and Production

  • Overall Project Management for timely development and launch of products• New Product Introduction (Tablet, Capsule, Syrup, Suspension) in ROW market• Process Improvement and optimization• Monitor commercial production of Tablet, Capsule, Syrup, and Suspension.• Raw Material Planning• Equipment restoration• Technology transfer management• Draft and review Master batch records and Master Packaging record• Draft and review of Specification, STP, SOP • Stakeholder relationship management• Cross learning of past knowledge Show less

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  ALEMBIC RESEARCH LIMITED

  Sept 2013 - Sept 2016

  Process Engineer and Scientist, MS & T/ PDL/ Technology Transfer

  Pre-validation and Validation activities:Planning, execution and delivery of New Launch, site transfer, Cost improvement Projects pertaining to regulatory market like USA, Canada, EU, Aus, Brazil, ROW and so forth.1) Coordinate activities with BD, PPIC, Production, QA, Regulatory, QC departments to meet validation batches schedule. 2) Finalize pre validation and validation batch size with respect to market forecast, equipment availability, capacity and regulatory requirements.3) Documentation: To prepare Validation Batches Protocol/ Report and validation batches. To review BMR, Hold time study report, Stability Protocol.4) Monitor pre-validation batch, evaluate data of critical process parameters. Prepare report with key findings and recommendation for commercial Validation batches. 5) Assist and provide required documents like Change Control, Deviation. Pre-Exhibit and Pilot Activities:1) Coordinate planning activities with BD, F&D, production, QA, QC departments. 2) Assist to decide the pilot batch size with respect to equipment availability, capacity and regulatory requirements to F&D.3) To monitor Pilot batch in presence of F&D, identify critical process parameters.4) Provide technical support & Trouble shooting during exhibit batches.5) Prepare product evaluation report of exhibit batches with recommendation for intended BMR for commercial validation.6) Stability protocol, hold time study protocol etc.7) Execute tooling feasibility trials, process optimization trials at lab and manufacturing scaleContinuous Improvement Projects:1) Yield improvement,2) Cycle time reduction,3) Improve Cpk of Key CQAs,4) Alternative Vendor Development for de-risking and Cost optimization.5) Optimization of key process parameters.6) Root Cause Analysis and Risk Management Show less

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  Amneal Pharmaceuticals, Rajoda (US and Europe Market)

  Oct 2016 - Sept 2018

  Process Engineer and Scientist, MS & T/ PDL/ Technology Transfer

  To plan, execute and deliver Scale up and validation batches for new commercial launch and site transfer of products (OSD like Tables, Capsules) in regulatory markets like USA, Canada, Aus, EU, Row and so forth on budget and time.1) Data analysis of pilot and exhibit batches to identify key process parameters and challenging CQAs. Prepare and present deck to HODs (CFT) to highlight the findings and recommendations to be followed while executing commercial validation batches.2) Stakeholder management: Alignment with HODs (CFT) on identified finding and actions.3) Program management: To track defined milestones. Highlights the pit falls, delay, challenges to leaders falling red as per project plan to get close support and push.4) Execution of batches at shop floor: Troubleshoot and debug manufacturing process issues observed during Scale up & Validation Batches. Provide effective CAPA, systematic change to improve robustness of product.5) It includes Immediate Release, Extended Release (Matrix or Function coating or both), ER and MR Pellets, Blend prepared with Dry, wet granulation as well direct compression.6) Prepare/ review regulatory and technical documents like Process Validation Report/ Protocol, Spec, STP, BMR, MFC, BPR, Change Control, CAPA.Identification and project management of cost reduction projects like.1) Alternative Vendor Development for de-risking and to optimize cost2) Improve % Yield3) Reduce cycle time and change over time.4) Optimize over ages and excess RM part of BOM.5) Reduce testing and eliminate test to control overhead costs.Key Achievements:1) Project management, execution & timely launch of 30+ new products, 15+ Site transfer products in USA Markets. 2) Delivered, 10 + Yield improvement Projects, 8 + Change over time and cycle time reduction projects.3) 5+ Products to reduce overages of RM by optimizing process parameters & data analysis.4) 6+ Reduce and elimination of testing based on statistical analysis. Show less

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  JUBILANT GENERICS LIMITED

  Sept 2018 - Apr 2020

  Ass Mng Business Ex. | Business Analytics | PQCDSM Proj. | Process Expert | LSS | Conti. Imp.

  Responsible driving Six Sigma Green belt projects across the Jubilant Manufacturing site located in Roorkee. Lead multiple Op Ex projects to improve overall throughput for Dosage business.1) Data analysis of past FY data to identify projects to transform business in domain of operation, quality. Project planning, execution and review. Managing project delivery on budget on time and meeting customer expectations.2) Overall product yield improvement through advance statistical data analytics. Overall RM cost reduction by INR ~ 47 Lacs.3) Implemented dozens of Kaizens to improve productivity, safety, ergonomics and output.4) Bottle and blister size reduction to optimize shipper size and reduce freight cost of consignments significantly – Saving ~54 Lacs.5) Yield improvement, cycle time reduction, Alternative Vendor Development – Saving ~64 Lacs. Improve Sigma level up to 5 for 3 CQAs to re-commercialize products in which failure was observed.6) Improve overall productivity of bottle packaging line by 15% through Lean implementation.Key Achievements –1) Overall 1.5 Cr of saving by delivering aforementioned projects2) Chairman award from MD of Jubilant, Mr. Bhartia on Cost Reduction Projects.3) Award from CEO of Jubilant Life Science for implementing best Sankalp at site.4) Re-commercialization of 2 products by improving sigma level of CQAs in which failure were logged. Revenue of these products were 10+ Cr for particular FY. Show less

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  Lupin India

  Apr 2020 - Dec 2023

  Manager, Op Ex | LSS Deployment | Cont. Impro. Coach | Digital Dashboard | Project Mngm | RCA

  I integrate Statistical analysis, Data Visualization, Process expert & Strategic management skills to identify areas to transform business performance in domain of Quality, Operations and Service across 5 regulatory formulation Sites (India).1) Identify, plan, drive & deliver projects to improve quality (Sigma level of CQAs), yield, OEE using Lean Six Sigma. Set governance & review with sponsors to deliver project on budget on time.2) DMAIC methodology for Root Cause Analysis, Process Improvement to meet Quality expected by B2B Customers.3) Led a project of Digital Dashboard on quality with meaningful charts, graphs & tables to get insights on performance & health of Products based on past performance. 4) Exploratory data analysis to identify golden batch (GB) & key process parameters. Replicate key parameters of GB to improve overall health of product.Key Achievements:1) Successfully led & delivered 70+ CQAs to improve 6 sigma level using DMAIC, Technical & Statistical skills. Rejection of batches reduced from 40 to 1 per year among these products.2) Led 5+ products to identify RCA based on past knowledge, statistical analysis & process expert in 2 months. Post recommendation products were with 4 + Sigma level for all CQAs including CQAs in which failures were logged. The total revenue post re-commercialization is ~ 30+ Cr.3) 15+ Products to improve Yield & reduction in Change over, Cycle time using lean concepts. Total saving of ~ 3+ Cr.4) Golden batch analysis of 4 products to control failure due to high variability coming from Raw Materials, key process parameters & analytical method. 5) N no. of dataset were given meaningful shape from scratch by creating Quality Dashboard giving key insights & recommendations which can transform business & bring significant value.6) Ideal quality lab layout design to reduce contamination & improve efficiency of glassware washing.7) Mentored 20+ belts on LSS projects. 8) Knowledge management Show less

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  Gulf marketing group

  Jan 2023 - now

  Business Process Improvement Assistant Manager