Wipro Technologies - East Brunswick, NJ since Mar 2012
Lead Validation Consultant
Merck - Kenilworth, NJ Jan 2011 - Mar 2012
Quality Service Partner for Informatics, Pipeline & Project Management and WorldWide Licensing
Merck - Kenilworth, NJ Oct 2005 - Jan 2011
Technical Assurance Partner / Principal Analyst
PLIVA - East Hanover, NJ Sep 2002 - Oct 2005
Computer and System Validation
Dow Jones - Princeton, NJ Oct 1999 - Sep 2002
Sr. Project Manager
Education:
New Jersey Institute of Technology 1995 - 1997
Master, Management Information Systems
Stevens Institute of Technology 1995 - 1997
Certification Program, Project Management Certification Program
Case Western Reserve University 1990 - 1992
BSE, Computer Engineering
Pontifical Catholic University of Puerto Rico 1987 - 1990
BS, Life Science
Skills:
Computer System Validation 21 Cfr Part 11 Change Control Validation Quality Assurance Sdlc Gxp Project Management Fda Process Improvement Software Documentation Pharmaceutical Industry Quality System Pmo Gmp Business Process Improvement Full Sdlc Clinical Trials V&V Gamp Sop Cgmp Manufacturing Cgmp Practices Project Portfolio Management Quality Assurace Management Quality Management and Operational Excellence Cross Functional Team Leadership Management Vendor Management U.s. Food and Drug Administration Regulatory Requirements Leadership Microsoft Office Continuous Improvement Lean Six Sigma Biotechnology Medical Devices Good Clinical Practice Corrective and Preventive Action Strategy Good Laboratory Practice Consulting Regulatory Affairs Research and Development Iso 13485 Pharmaceutics Quality Auditing
Interests:
Business Development Organizational Process Improvement Quality Manager