Valsource, Llc
Principal Consultant
Concordiavalsource
Senior Consultant
Shire May 2009 - Sep 2012
Associate Director
Shire Aug 2004 - Apr 2009
Associate Director, Global Pharmaceutical Technology Validation
Pfizer 2002 - 2004
Group Leader
Education:
Rochester Institute of Technology
Rochester Institute of Technology
Bachelors, Bachelor of Science, Mechanical Engineering
Rochester Institute of Technology
Masters, Applied Statistics
Skills:
Validation Gmp Pharmaceutical Industry Fda Technology Transfer V&V Sop 21 Cfr Part 11 Quality Assurance Biotechnology Change Control Biopharmaceuticals Capa Pharmaceutics Cleaning Validation Gxp Regulatory Affairs Quality System Computer System Validation Process Simulation Manufacturing Medical Devices Formulation Iso 13485 Lims Glp Lifesciences Regulatory Requirements Clinical Trials Product Development Regulatory Submissions R&D Pharmacovigilance Lean Manufacturing Vaccines Aseptic Processing Gcp Oncology Laboratory Drug Discovery Quality Control Quality Auditing Drug Development Gamp Protocol Analytical Chemistry Six Sigma Clinical Development Cro Hplc
Interests:
Cooking Electronics Home Improvement Reading Crafts Gourmet Cooking Home Decoration