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KUNAL PATEL 170 Tonnelle Avenue, Jersey City, NJ-07306 Email: kp1190b1e@westpost.net kunal_pharmacy@yahoo.co.

in Phone: (201)233-0858 OBJECTIVE: Thoroughly knowledgeable about all the branches of the pharmaceutical industry, including drugs, medical equipment and health care services, I am looking for a position where I can contribute in providing better medical facilities to the co mmunity. * M.S in Pharmaceutical Manufacturing * 4+years of experience in Pharmaceutical Industry EXPERIENCE: ALIVE PHARMACEUTICAL PVT LTD (Dermatology, Solid and Liquid Manufacturing Plant) (January'06-December'08) Ahmadabad, India. (CGMP Appliance) Assistant Manager * Preparation of SOP, Protocols, P&IDs. * Preparation of material requisition, technical specification. * Preparation of bid evaluation and vendor document and validation reports. * Served as liaison between company and peer organizations, communicating variou s issues and troubleshooting and resolving problems. PARAS PHARMACEUTICAL PVT LTD (Personal Care Product/Health Care Products) (January'05-December'05) Internship Ahmedabad, India. * Responsible for Plant optimization, process troubleshooting, production planni ng. * Responsible for Plant emergency control, implementing safety systems. * Responsible for research activities to develop test products and also for qual ity control. * Industrial Documentation and QA maintains. ALIVE PHARMACEUTICAL PVT LTD (Dermatology, Solid and Liquid Manufacturing Plant) (March'04-November'04) Ahmadabad, India. (CGMP Appliance) Internship Chemist * Check the quality of raw materials and finished goods. * Receiving, triaging, reviewing and processing Lifecycle Safety data. * Performing data entry, tracking and Lifecycle Safety databases. Served as liai son between company and peer organizations, communicating various issues and tro ubleshooting and resolving problems. EDUCATION: STEVENS INSTITUTE OF TECHNOLOGY (2 Year) Hoboken, New Jersey. * Master in Pharmaceutical Manufacturing o Intro. To Pharm. Manufacturing o Validation and Regularity Affairs in Pharm. Industry o Good Manufacturing practice in Pharm. Industry o Intro. To Project Management o Pharmaceutical Finishing and Packaging o Bioprocess Technology in API Manufacturing o Design and Management of Aseptic Pharmaceutical Manufacturing Process o Study on Project Management and Validation * Project work During My Master o Project on "Tablet Coating Equipment used in Pharmaceutical industry and which

Equipment is best among all them." o Project on "Sterility testing for Non-sterile Products." o Project on "Standard Operating Procedure For Manage the design, Construction, Installation and Commissioning of new Aseptic Facility" o Project on "Issue and Challenges with Biopharmaceutical Manufacturing Failure" o Project on "New Drug Application" * Validation Project o Reviewed developmental studies, SOPs ,lab reports and risk analysis documents o Developed FMEA for design, process and equipment o Authored and Executed IQ, OQ and PQ protocols for manufacturing equipment at l ab scale and Process Validation protocol and documentation of each report includ ing deviations o Prepared and maintained logbook according to GMP standards o Prepared SOP and Validate Spreadsheet for the Content Uniformity o Developed and Validate swab sampling method using TOC analyzer for cleaning va lidation S.E.T's College Of Pharmacy (4 Year) (Bachelor) GPA 3.88 * Good Knowledge of Pharmacological and Pharmacokinetic actions of Different dru gs. Laboratory Skills: Formulation and evaluation of pharmaceutical products, dissolution apparatus, an d disintegration apparatus, diffusion study apparatus, Swab sampling, Total Orga nic Carbon (TOC), HPLC, UV,GC Professional Reference provided up on request

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