Jorge Sugranes brings over 32 years of direct and combined experience in Quality Management Systems (QMS), Validation, regulatory compliance, risk management, and project management from the Pharmaceutical and Medical Devices regulated manufacturing industry.
Mr. Sugranes has extensive experience gained from various technical and managerial functions such as Director of Validation & Quality Risk Management, Associate Director Manufacturing Science & Technology (MS&T), Plant QA Manager, Senior Manager QA Regulatory Compliance, Validation Manager, Project Manager, Validation Engineer, and others. He worked in Puerto Rico, Madrid Spain, Barcelona Spain and continental USA (Texas, Michigan, Colorado) in companies such as Raytheon, Lederle Parenteral (Wyeth/Pfizer), Alcon, Novartis, CareFusion, and Johnson & Johnson.
Mr. Sugranes is proficient on pharmaceutical GMPs (21CFR 210/211), medical devices QMS (21CFR 820, ISO 13485), and combination products (21CFR Part 4), including sterile medical devices, aseptic processes, parenteral products, sterile liquids, and solid dose manufacturing operations. He is able to evaluate Quality & Compliance risks, balance findings with customer and business needs to make quick decisions that are defendable with data. In addition he is experienced leading companies through periods of dramatic change and compliance challenges.
Mr. Sugranes obtained a BS in Biology from the University of Puerto Rico, BSIE in Industrial Engineering, a Master degree in Engineering Management both from the Polytechnic University of Puerto Rico, a Master of Science (MS) Mechanical Engineering Program, and Doctoral degree candidacy in Engineering both from Southern Methodist University (SMU) in Dallas Texas, with extensive research work on electrons beam radiation sterilizationas part of his doctoral program. Is the author of various technical publications with the most recent on Electron Beam technology published by the International Society for Pharmaceutical Engineering (ISPE), and the Journal of Validation Technology.
Mr. Sugranes is a Certified Manufacturing Engineer (CMfgE) and Certified Professional Consultant (CPC). Is active member of the Professional & Technical Consultants Association (PATCA), the International Society for Pharmaceutical Engineering (ISPE), American Society of Mechanical Engineers (ASME), and other professional organizations.
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