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RINESH PALKHIWALA 12 Vincent Road Chelmsford MA 01824 PROFESSIONAL SUMMARY Manufacture and package Solid Dosage and Parenterals

in Lean manufacturing cult ure Manage and execute equipment, process & product validation protocols Author, Review, and approve SOP, Protocols & Batch records Root Cause Analysis and Deviation writing in Trackwise Conclusion and execution of CAPA Write and review Change Request for SOP and Batch Records through TDMS Conduct classroom training as well as On-Job -Training Evaluate and acquire capital equipment in communication with upper level manage ment Design and validate clean room/environmental control room facility & utilities Validate sterilization process and equipment Resource management, team building, leadership & problem solving Facility and utilities maintenance PROFESSIONAL EXPERIENCE AstraZeneca, Westborough, MA 2008 - current (h) 978-256-1620 rinesh.palkhiwala@gmail.com (c) 978-302-6057

As a Production Manager [Process facilitator], leading the team of 16 to 20 dire ct reports for fill to package operation for Sterile Injectable products. Managed filling, inspection and packaging operations for Parenterals products i n Lean culture. Author, Review, and approve SOPs, Protocols & Batch Records Root Cause Analysis for deviation, using techniques like 5 whys, cause & effec t diagram Deviation writing in Trackwise Conclusion and Execution of CAPA Writing CRs for SOP and Batch Record changes through TDMS Led the Environment Monitoring improvement project for aseptic area Conduct classroom trainings well as On-Job -Training Resource management, team building, leadership & problem solving Coaching and Mentoring subordinates Amerifit Pharma, Inc. (previously PolyMedica Pharmaceuticals), Woburn, MA 1997 2008 Manufacturing at Amerifit Pharma includes 10 different Rx pharmaceuticals, OTC d rugs and nutraceuticals in solid dosage forms - tablets and suppository with ann ual sale of over $20 million. Operations Manager (Joined as a supervisor; promoted to Manufacturing Manager in under five years; then promoted to Operations Manager) Managed manufacturing, packaging, warehouse operations, and facility maintenanc e. Managed two direct reports and 14 indirect reports. Designed and executed IQ, OQ and validation protocols for different equipments and processes. Reviewed and approved SOPs and lot history cards. Evaluated and bought capital equipment, raw materials and packaging components. Managed and audited suppliers and vendors for material and service contracts.

Supported formulation development activities and manufacture of prototypes and pilot lots. Managed hiring, training program and performance evaluation. Maintained effective communication with business partners and upper level manag ement. Coordinated with state & local agencies like DEP, MWRA, and town fire departmen t. Collaborated directly in FDA inspection. Helped CSR & QA for post market monitoring & issue resolution. Core Healthcare Ltd., India Production Manager Parenterals, 1995 1997

A leading manufacturer of Parenterals, using Blow-Fill-Seal technology of Romelo g, with product size varying from 1 ml ampoule to 1 liter bottle. Designed and constructed clean room for Aseptic Manufacturing coordinating with the architect, engineers, and QA/QC. Validated clean Room, including particle count, air changes, media filling, HEP A filter validation. Validated steam sterilizers. Procured, installed, validated and commissioned equipment and machinery for ste rile products in coordination with finance, equipment manufacturer, engineers & QA/QC. Prepared SOPs and validation protocols for aseptic manufacturing processes. Designed batch records required as per FDA and ISO 9000 audits. Managed ten direct reports and 70 indirect reports. Cadila Laboratories Pvt. Ltd., India Section Manager Parenterals 1992 1995

An ISO certified manufacturer of Parenterals; the product mix include antacids, antibiotics, and multivitamins. Scheduled production, while maintaining quality, yield and cGMP standards for a septic manufacturing. Maintained records as required by FDA and ISO 9000 audit. Provided training to qualified associates. Scrutinized and approved all the batch cards at the end of process. Managed six direct reports and 60 indirect reports. Torrent Pharmaceuticals Pvt. Ltd, India Manufacturing Supervisor Parenterals 1990 1992

A US FDA approved company, having technical collaboration with Novo Nordisk of D enmark; manufacturer of insulin injection formulations. Supervised production activities for sterile products. CIP, SIP for mixing tanks, 0.2micron filter sterilization and test for integrit y. Validated Laminar flow workbench and steam sterilizers. Validated aseptic manufacturing area by particle count, air changes, and media filling. EDUCATION L.M.College of Pharmacy, India Bachelor of Science in Pharmacy (Pharmaceutical Engineering) SPECIALIZED TRAINING Massachusetts Biomanufacturing Center, University of Massachusetts, Lowell, MA Successfully completed a six weeks Biopharmaceutical Industry Summer Training C

ertificate Program PROFESSIONAL DEVELOPMENT Quality Systems Approach to cGMP Regulations by Institute of Validation Technol ogy 5-Day MBA workshop by American Management Association. Assertiveness Skills for Managers