Description
SUMMARY IT/QA PROFESSIONAL Biotech - Pharmaceutical - Medical Device - Life Sciences Highly skilled consultant and Project Manager with diversified domestic and international experience and a background that incorporates strong technical orientation with business skills. Hold proven record of success in product development, process improvement, cGMP compliance, validation and quality control. Examples: * Software Implementation, Configuration, Support: (at all levels) * Extensive validation experience involving hardware, equipment (including robotics), software and IT infrastructures * Completed more than 85 projects for mission-critical applications involving clinical trials, EDC, ERP, LIMS, LEMS, * Fully conversant in 21 CFR Part 11 and best business practices impacting regulatory, clinical, manufacturing and safety groups. Gilead Sciences Validation / Compliance Lead April 2017 -present N.A. Responsibilities * Develop process for Vendor selection for New LIMS projects Manufacturing Ohio site * Develop SOPs, Training Procedures across multi-sites, Validation Protocols', Qualifications for commissioning, decommissioning, * Test scripts (IQ, OQ, PQ) [Skids & Valves], holding tanks, filtration systems, and batch reactors, SIPs. * QC Stability Commercial release San Diego, CA * Stability Chambers Analytical Research and Development * POC for Global ABI LIMS * Bioanalytical labs Watsons LIMS and W. European countries) Intake of (SAEs and SUSARs)
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