Regional Manager, VTI Life Sciences
Regional Manager and Computer Validation Professional with extensive experience in Automation & Computer Validation and managing validation projects at various clients.
Experienced in implementing and maintaining the following Enterprise wide applications:
• Enterprise Resource Planning (ERP) – Ross ERP Enterprise Application,
• Laboratory Information Management System (LIMS) – Novatek International,
• Electronic Common Technical Document (eCTD) – ISI Image Solutions,
• Pharmacovigilance System – PhaseForward Clintrace Application,
• Regulatory Asset Management – Blue Mountain,
• Enterprise Quality Management – TrackWise by Sparta,
• Report Server – Crystal Enterprises by Business Objects
• SAS Analytics Pro – SAS
Experienced in qualifying GxP Spreadsheets as well as validating HPLC and GC Laboratory Analytical Instruments.
Developed company wide Computer validation methodology to implement and maintain computerized system in a validated state. Including Computer Validation Policies and Procedures for use corporately covering all aspects of the Computer Validation process.
Full understanding of the challenges and issues Pharma IT departments are facing. Have 10+ year plus background in IT.
Specialties: Computer systems validation, regulatory compliance, computerized sytems risk management and IT solutions