shailesh mavadiya
Assistant General Manager - API Production. at ALEMBIC LIMITED- Claim this Profile
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Bio
Experience
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ALEMBIC LIMITED
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United Kingdom
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Chemical Manufacturing
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1 - 100 Employee
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Assistant General Manager - API Production.
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Apr 2020 - Present
Overseeing production related tasks including planning, control and trouble shooting. Setting up production targets and achieving the same within time and cost parameters. Handling process operations to ensure timely completion of production targets within pre-designated time and cost parameters. Ensuring effective resource planning for optimizing man & machine utilization, reducing wastes for enhancing productivity and profitability. Participating in failure investigation (out of specification) and conducting causal analysis of the problem and identifying major root causes and their remedies. Managing trouble shooting of regular production. Effectively developing:o New process concepts for production optimization and yield improvement.o Guidelines for the sequencing of manufacturing activities on the shop floor (SOP).o And scaling up for new products.o Cost effective & smooth synthesis processes. Show less
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Senior Manager-API Production & Solvent Recovery.
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Apr 2017 - Apr 2020
Developing the relations with parent organisation and local Regulatory /Administration Authorities. Heading and mentoring the staff to work continuously for Industrial Excellence and Continuous Improvement (in processes, technologies, people and customer satisfaction). Ensuring the compliance of Legal and Statutory requirements of various Government Department. Supervising Executives, Plant Operators to ensure better productivity and quality. Overseeing compliance of SOP’s for Warehouse, Engineering & Production Plant for audit. Ensuring day to day documentation work checking regarding internal and external audit. Handling the change controls and deviations related to production activities. Preparing compliance report for both internal and external audits. Show less
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Manager- : API Down Stream Processing
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Jul 2012 - Apr 2017
New Product developmental work likes Compactin, Valencene, Surfactin Capacity enhancement of Lovastatin with updating of plant. Successfully planned & scheduled the production as per marketing requirement. Implemented and controlled budgeted RM consumption & cost. Effectively maintained cGMP & HSE in the production area.
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Deputy Manager
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Jul 2010 - Jul 2012
Successfully planned & scheduled the production as per marketing requirement. Implemented and controlled budgeted RM consumption & cost. Effectively maintained cGMP & HSE in the production area.
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Assistant Manager- API Production & Compliance
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Mar 2007 - Jul 2010
Ensuring compliance to Corporate & Local Quality, EHS and Regulatory requirements. Handling effective technology transfers from lab/out source to production plant. Assuring and ensuring dependable and quality delivery performance to create high customer satisfaction. Played a pivotal role in upgrading down level employees regarding process, operation, new equipments, SOPs and other qualification & validation activities. Effective communicator with management skills & strong problem solving abilities. Imparted training to personnel in production relating to cGMP. Show less
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Alembic Pharmaceuticals Limited
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India
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Executive - QMS & Manufacturing
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Jan 2004 - Mar 2007
Initiation of CAPA based on the deviation, execution of CAPA and closing / extension and get it approved from Quality Assurance within time. Initiation of CAPA effectiveness check, execution and closing within time. Initiation of change control , preparation of impact assessment, approval of change control and closing of change control . Preparation / revision of SOPs, Batch Processing Record and Batch Cleaning Records. Requalification of equipment as per VMP schedule. Review of online production related documents, cross checking of batch processing record, review and submit to Quality Assurance. Review batch record for cleaning after product change over cleaning / campaign change over cleaning; submit batch record for cleaning to Quality Assurance and take area clearance for product manufacturing. To plan the activities as per instruction. Issuance of BPR, SOPs, Equipment logs and user copy Formats of SOPs from Q.A. Show less
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ALEMBIC LIMITED
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United Kingdom
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Chemical Manufacturing
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1 - 100 Employee
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Officer- API Production
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Apr 2000 - Jan 2004
Part of Process Development Team. Effectively managed workmen, chemist and junior officer as per the requirements in shift and work. Kept a track of pollution control, safety precaution and house-keeping with cGMP. Gained exposure of: o Batch-wise Semi-continuous Plant.o Unit Operations: Multistage Counter Current Extraction, Moist Heat Sterilization, Air Handling Unit Leaching, Filtration, Crystallization, Distillation and Drying.o SAP ERP Package.o Face the GMP, ISO-9001: 2000, ISO-14001. Show less
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Sr. Production Assistant
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Apr 1998 - Apr 2000
Issuance of BPR, SOPs, Equipment logs and user copy Formats of SOPs from Q.A. Production planning, control and responsible for achieving production targets. Scheduling and executing preventive and shutdown maintenance jobs for production equipment in coordination to maintenance dept. Handling independently plant in shift for achieving production target. Cross checking the raw material with respect the batch No., Qty. and approved Labels on the Container before batch charging. Effective Communication to Superior as well as subordinates in order to carry out work and follow up. Co-Ordinate with other related dept., such as Q.C, Q.A, Electrical, Instrumentation, and Maintenance and safety. Reporting of abnormalities/deviations in production activities immediately to Shift In charge. Production operations like batch charging, layer separation, filtration, heating-cooling operations, drying, distillation, centrifuge and powder processing. Record keeping of daily activities in the concerned logbooks. Filling of BPCRs and other production related documents neatly and on time. Show less
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Quality Control Microbiologist
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May 1992 - Apr 1998
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Gujarat Water Supply Sewerage Board(GWSSB)
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India
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Utilities
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200 - 300 Employee
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Junior Scientific Officer- Gujarat Water Supply and Sewage Board
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Dec 1991 - May 1992
Executed Bacteriological and Chemical Analysis of water. Executed Bacteriological and Chemical Analysis of water.
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Education
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G.G. University
Master's degree -
Saurashtra University
Bachelor's degree, Chemistry