Highly qualified and goal-oriented chemist with twenty-three (23) years of pharmaceutical (Quality Assurance, Quality Control, Technical Service, Manufacturing and Regulatory Compliance) and scientific/technical exposure. Project Management, Validation, and Parenteral (Sterile Solutions) knowledge. Fourteen years (14) of experience working in Pharmaceuticals under Consent Decree (Schering-Plough, Baxter 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, Medical Device (ISO 13485, Part 820, 11, 50, 54, 56, 801, 803, 806, 807, 812, 814, 510K, PMA, 93/42/EEC and 7382.845), CGXPs (GMP, GLP and GCP), ICH, Quality Engineering and Quality Audit Principles, General Microbiological, 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, Biological Industries (Part 600,601 and 610), Canadian Regulation (SOR/98-282 and GMP 2009 Edition), Six Sigma Principles and Lean Manufacturing Principles. Knowledge in the Bioinorganic and Biochemistry area. College teaching experience. Certified as Food Safety Manager (CFSM), ASQ Certified Pharmaceutical GMP Professional (CPGP) and ASQ Certified HACCP Auditor (CHA). ASQ Six Sigma Black Belt Certification (CSSBB) in progress ( March, 2012).