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EXPERIENCE BACKGROUND

Chemist with more than of twenty-five (25) years of pharmaceutical (Quality Assurance, Quality Control, Technical Service, Manufacturing and Regulatory Compliance) and scientific/technical exposure. Fourteen years (14) of experience working in Pharmaceuticals under Consent Decree (Schering-Plough and Warner-Lambert) developing, establishing and maintaining quality programs. Knowledge of  USP/NF, BP, EP, JP, MHRA Regulations, TGA, Japan regulations, FDA regulations, Food Microbiology, SQF(1000 and 2000), Hazard Analysis Critical Control Point (HACCP), Food Code 2009, Food Safety Modernization Act (FSMA),Medical Device (ISO 13485 and Part 820), CGXPs (GMP, GLP,GAP and GCP), ICH, WHO (WORLD HEALTH ORGANIZATION), PIC/S (Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme)), Computer Literate (Word, Power Point, and Excel), TRACKWISE System, ISOTRAIN, Biological Industries (Part 600,601 and 610), Canadian Regulation and Six Sigma Principles and Lean Manufacturing Principles. College teaching experience. Certified as Food Safety Manager (CFSM), ASQ Certified Pharmaceutical GMP Professional (CPGP) and ASQ Certified HACCP Auditor (CHA). NEHA and Prometric Trainer and Proctor. National Registry of Food Safety Professionals Trainer and Test Administrator. Licensed Structural Pest Control Applicator.Writer collaborator of Spain Magazine Cielo, Mar & Tierra, Puerto Rico, Gastronomía Puerto Rico Magazine and China Food Safety Magazine.

 

 

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