Over 15 years of Computer Compliance, SQA and Risk Management experience in Information Technology and Computerized Systems for the Bio-tech/ Pharma Industry (FDA regulated environment). Expertise: • Develop IT Systems Compliance Policies and Guidelines, Strategic Implementation (for US and International) and Validation Methodologies based on GAMP 5 (Risk Based Approached to Compliant GxP Computerized Systems, Validation of Laboratory Computerized Systems, IT Infrastructure Control and Compliance) • Deep knowledge of 21 CFRs (part 11, 210, 211, 820), ISO 9001/ 13485, SOX, HIPAA and ITIL • Manage Compliance and Validation activities for large scale, software implementation (Oracle-Argus, Serialization, AD Architecture, etc) in regulated environment. • 10 + years of management experience, managing in excess of 15 resources. • Conduct Risk Assessments, FMEA • Develop Part 11/ Annex11 Remediation Plans • Develop and Implement project specific Change Controls and Computer Validation Plans. • Lead Internal and External Audits in adherence with applicable regulations, quality systems and corporate policies • Lead Validation efforts for large Enterprise Applications (i.e. Argus Safety, eCTD, Prisma, SCCM, HIPS, Livelink, CATSWeb, AD, Oracle, PDMS, Provantis, TrackWise, etc). • Validation of GxP Systems (Labs, Automated/ Control Systems – i.e Delta V, PLC, etc). • Validation of Controlled Database/ Application Servers (Rapid Servers, Oracle Database, various Application Servers). • Validation of Clinical and Regulatory Affairs Applications (Argus, Clinicopia, Wabin/ CDC, RMS, CTT, Electronic Submissions, etc) • Develop programs for CAPA resolution and trending to detect systematic issues. • Create and execute training programs on Quality systems, SDLC, GAMP, general GxP regulations and good practices. • Develop programs to harmonize and standardize compliance approaches for U.S. and International sites
Photography, Electronic Music, Sound Design/ Composing, Digital Video/ Editing/ Filming, Painting, Zen (Meditation), Iaido (Samurai swordsmanship), Cooking, Hiking,Traveling to Europe and everything art related...
- Sr. Principal Consultant at Boston Technology Research