CSV Services Manager

• Apr 2017 - Present

Senior Validation Specialist

• Sep 2011 - Present

Leads the Business Information Computer System Validation Performance Validation team, including strategic and business development activities.Responsible for validation projects of client’s computerized systems including consultation and life cycle documentation development and execution to ensure systems meet regulatory and intended use requirements.Project Responsibilities:• Project Management• Business Analysis• System Risk Assessment• Supplier Audit and Assessment• Validation Master Planning• Specification / Requirements Development (URS, Functional, Configuration)• Software Quality Testing• Test Script / Protocol Development and Execution (IQ/OQ/PQ/UAT/Regression/Stress)• Deviation and Issue Management• Summary Reporting• Standard Operating Procedure and Training Development• Audit / Inspection• System Retirement / DecommissioningSystems and Equipment Experience:• Clinical Pathology and interfacing• Laboratory Information Management Systems (LIMS)• HPLC / Mass Spectrometry• Laboratory Instrumentation Control and Data Analysis Software• Sample Tracking• Documentation Management Systems• Business Process Management – e.g. TrackWise• Quality Management Systems• Enterprise Data Collection Systems• Statistics Systems• Custom Developed Software Show less

Validation Specialist

• Sep 2011 - Jul 2012

Responsible for validation projects of client’s computerized systems including consultation and life cycle documentation development and execution to ensure systems meet regulatory and intended use requirements.

Group Leader Systems Compliance

• Nov 2006 - Sep 2011

Manage a team at a Contract Research Organization (CRO) in the pharmaceutical industry, who are responsible for validation (providing assurance through documentation and testing) that the company’s computerized systems meet regulatory requirements (GLP, cGMP) and operate according to intended production use. Manage a team at a Contract Research Organization (CRO) in the pharmaceutical industry, who are responsible for validation (providing assurance through documentation and testing) that the company’s computerized systems meet regulatory requirements (GLP, cGMP) and operate according to intended production use.