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This document provides a summary of Ashwini Kumathekar's work experience and education. It details her roles in planning, scheduling, and production management for pharmaceutical companies like Cipla Ltd and Reliance Life Sciences from 2007 to the present. Previous experience includes quality control analysis and handling internal meetings and documentation. Education includes an MBA in International Business Management and a BSC in Biotechnology. Skills listed are proficiency in Microsoft Office and SAP modules.
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![ASHWINI KUMATHEKAR
Mumbai • 7738410993 • ashwini.ghangale@yahoo.in
PPIC-Loan License & Third party contract manufacturing
Developed procedures for new planning position.
Achieved 100% ship-to-commit rate through expert planning and scheduling activities.
Streamlined new product introduction by creating release-to-production checklists.
Trained new planners and engineers on product lines.
Analyzed work flow; planned and scheduled customer orders based on materials availability, machine
capacity and constraints for production; During tenure helped production increase by 65%
Maintained strong vendor relationships; working with vendors to communicate quality and delivery
issues
Handled customer complaints including physically visiting customer plants and collaborating with
production engineers to identify and solve issues thus reducing customer complaints by 20% during
tenure
Facilitated Root Cause Failure Analysis Investigations in regard to safety and equipment failures
Got FDA approval in 2013 for aseptic filling.
2014 - current PPIC-Loan License & Third party contract manufacturing
Cipla Ltd
Handling entire process starting from Forecasting, material planning, ordering follows up
Production Plan Execution to TP / LL as per Prod. Capacity for all dosage forms ( Solid, Liquid, Sterile
& ointments)
Streamlined new product introduction by creating release-to-production checklists.
Attend & organise Quality and Business Review Meetings as required.
Updating Weekly OTIF (Schedule OTIF & Plan Vs actual OTIF), Stock out List ; EOQ file for each SKU,
Preparation of MIS on monthly and weekly basis.
Trained new planners and engineers on product lines
Achieved 100% ship-to-commit rate through expert planning and scheduling activities.
Analysed work flow; planned and scheduled customer orders based on materials availability,
machine capacity and constraints for production; During tenure helped production increase by 65%
2007 - 2014 MANAGER, OPERATION & PLANNING
Reliance Life Sciences
Project Planning & Process Design
Commissioning:
Review and updating P&IDs, PFDs and Isometrics. Execution of CTPs, and Prepared of SOPs, Review
of FAT, SAT & CTP documents for critical equipment in the cGMP facility, Worked as Technical
Specialist for process equipment and involved in FAT, SAT, Automation review and testing
Involved in Planning, Scheduling, co-ordination with various departments and executing the
Commissioning of cGMP Plant.
Lead the team of passivation in newly commissioned facility.
Validation:
Did DQ/IQ/OQ/PQ for CIP unit, TFF system, Autoclave & Ion exchange chromatography & DCS [Digital
Control System].
Summary
Work
History
https://www.visualcv.com/wx0abhwa0yo](https://image.slidesharecdn.com/9691a979-38bb-4125-bcb7-61769e7b8bc9-160817195151/85/Ashwini_Ghangale_new-1-320.jpg)
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Robert Miller has over 25 years of experience in manufacturing operations and is a certified Lean Black Belt. He has a proven track record of leading teams to implement processes that reduce costs, cycle times, and improve quality. Miller is proficient in Lean tools and has achieved over $1 million in annual savings through Kaizen events. He has extensive experience in roles related to continuous improvement, materials management, cost engineering, and production planning.
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Harpreet Singh is seeking a position in the pharma industry utilizing 19 years of experience in areas like equipment validation, production, quality assurance, training and regulatory compliance. He has hands-on experience with FDA, EU, WHO and other regulatory guidelines. Key projects include setting up a new spray dryer plant and qualifying a microbiology lab. He is proficient in systems like SAP, MS Office and learning management systems.
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Prabhasini Sahu is seeking a position in quality management where her 6.7 years of experience in quality assurance can help improve productivity. She has experience with change control, validation, batch release, and ensuring compliance with regulatory inspections at Hospira and Cipla Ltd. Her roles included equipment qualification and validation, in-process quality checks, batch document review, and audit preparation. She is proficient with quality management software and systems and has faced audits from regulatory bodies like USFDA, MHRA, and TGA.
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Kanwaljit Singh has over 10 years of experience in manufacturing and maintenance roles. He currently works as an Assistant Manager at GlaxoSmithKline, where he is responsible for managing production processes and equipment maintenance. Previously, he worked at PepsiCo and ITC Foods in similar roles focused on production planning and quality control, maintenance planning, and ensuring compliance. He has a Bachelor's degree in Mechanical Engineering and additional qualifications in operations management.
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Angel Mario Jusino Berrios is an experienced registered pharmacist with extensive experience in the pharmaceutical industry, managing consent decrees and ensuring regulatory compliance. He has held senior roles providing quality consulting services, including implementation of validation guidelines, quality system assessments, and preparation of regulatory reports. Berrios has expertise in areas such as quality system implementation, process validation, remediation programs, auditing, and technical strategies.
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Cesar Espada is seeking a position as a line lead or quality assurance inspector and has over 5 years of experience in planning, operations, quality control, production, and warehouse work. He has a background in pharmaceutical manufacturing and medical device production. His resume lists experience in roles such as line lead, quality assurance inspector, and cleanroom technician at companies including Sun Pharma, Johnson & Johnson, and Zeus Inc. Espada has skills in areas like batch record review, sampling, inspection, inventory management, and computer programs like SAP and Minitab.
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R. Santhoshkumar has over 8 years of experience in quality control and manufacturing engineering functions in automotive and equipment manufacturing companies. He has expertise in inward and supplier quality assurance, new product development, part testing and validation, and implementing ISO quality systems. Some of his accomplishments include reducing customer complaints and supplier defects, improving production processes, and achieving zero non-conformances during audits. He holds a diploma in industrial engineering and has worked in roles of increasing responsibility at companies such as ELGi Equipment, Ashok Leyland, TVS Motor Company and TVS Sundaram Fasteners.
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The document provides a summary of Nikhil Mahajan's qualifications and experience seeking a role in quality management. It outlines his past work experience spanning over 15 years in quality assurance and systems roles at various automotive companies. It also lists his responsibilities in areas like new product development, supplier quality, quality systems, audits, and projects. His academic credentials include an MBA and BTech in Mechanical Engineering. Contact details and a profile outline are also included.
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- 1. ASHWINI KUMATHEKAR Mumbai • 7738410993 • ashwini.ghangale@yahoo.in PPIC-Loan License & Third party contract manufacturing Developed procedures for new planning position. Achieved 100% ship-to-commit rate through expert planning and scheduling activities. Streamlined new product introduction by creating release-to-production checklists. Trained new planners and engineers on product lines. Analyzed work flow; planned and scheduled customer orders based on materials availability, machine capacity and constraints for production; During tenure helped production increase by 65% Maintained strong vendor relationships; working with vendors to communicate quality and delivery issues Handled customer complaints including physically visiting customer plants and collaborating with production engineers to identify and solve issues thus reducing customer complaints by 20% during tenure Facilitated Root Cause Failure Analysis Investigations in regard to safety and equipment failures Got FDA approval in 2013 for aseptic filling. 2014 - current PPIC-Loan License & Third party contract manufacturing Cipla Ltd Handling entire process starting from Forecasting, material planning, ordering follows up Production Plan Execution to TP / LL as per Prod. Capacity for all dosage forms ( Solid, Liquid, Sterile & ointments) Streamlined new product introduction by creating release-to-production checklists. Attend & organise Quality and Business Review Meetings as required. Updating Weekly OTIF (Schedule OTIF & Plan Vs actual OTIF), Stock out List ; EOQ file for each SKU, Preparation of MIS on monthly and weekly basis. Trained new planners and engineers on product lines Achieved 100% ship-to-commit rate through expert planning and scheduling activities. Analysed work flow; planned and scheduled customer orders based on materials availability, machine capacity and constraints for production; During tenure helped production increase by 65% 2007 - 2014 MANAGER, OPERATION & PLANNING Reliance Life Sciences Project Planning & Process Design Commissioning: Review and updating P&IDs, PFDs and Isometrics. Execution of CTPs, and Prepared of SOPs, Review of FAT, SAT & CTP documents for critical equipment in the cGMP facility, Worked as Technical Specialist for process equipment and involved in FAT, SAT, Automation review and testing Involved in Planning, Scheduling, co-ordination with various departments and executing the Commissioning of cGMP Plant. Lead the team of passivation in newly commissioned facility. Validation: Did DQ/IQ/OQ/PQ for CIP unit, TFF system, Autoclave & Ion exchange chromatography & DCS [Digital Control System]. Summary Work History https://www.visualcv.com/wx0abhwa0yo
- 2. After successful completion of equipment & system validation, carried out media hold as well as media fill studies. After all studies carried out validation large scale up batches. Process : Supervision of the daily production activities with adhering to quality standards, c-GMP. Involved in Flawless production .Organizing & planning of daily Production targets & achieving them in the stipulated time. Routine production activities of the department like Manpower allotment, Dispensing, Issuing documents etc. Documentation: Preparation, implementation and review of Standard Operating Procedures (SOP) for all the activities of the department pertaining to area, men and machine in coordination with Quality Assurance Department. Preparation, online documentation & review of BPR as well as MFR Documenting & Closing Change controls, Process deviations, & product changeover. Audits: A team member in successfully facing for no of audits for plasma protein plant such as WHO, Indian FDA, ,ANVISA,Invima,PICS. 2005 - 2007 QC Analyst Sorbe Biotechnology Quality control of enzymes used in the textile industry such as cellulase, catalase, amylase used for different processes of fabric treatment. Execute purchase orders & scrutinize dispatch details. Handling internal agenda & organizing meetings. Drafting documents pertaining to export and import orders & further handling of the same. 2011 - 2013 MBA International Business Management ICFAI University 2004 - 2005 BSC Biotechnology Mumbai University MS Office MS Word Excel, Power Point, Word SAP PP, MM modules I declared all the given information is correct; if any documents need for verification that will be provided. Yours truly, Place:Mumbai Ashwini Kumathekar Education Skills Text Section https://www.visualcv.com/wx0abhwa0yo