Ghent Metropolitan Area
7 years as a sr Program Manager 12 years as a project lead for pharmaceutical industries 20 years of Gui engineering (html, javascript, flashscript, lingo, authorware) 20 years of interface design (illustrator, photoshop, Flash, Director, Authorware) 14 years of application development (C#, Visual Studio ) 14 years of software validation for highly regulated industries 3 years of project lead capital projects pharmaceutical industry -------------- Job titles: Gui engineer Senior developer Senior validation engineer ----------------------------- Projects: Project leader upgrade project filling line Project engineer Process Automation Pfizer Validation of EHP Automation (ERP - MES - SCADA) at Nestlé Nunspeet (the Netherlands) Development of d-Tracker (Private) Implementation of d-Tracker at MSD Oss Equipment Validation Filling & packaging line at Janssen Pharmaceutica Beerse Validation consulting advice for Nestlé Konolfingen (Switserland) Validation of CPL software Terumo Paris (France) Development of Product LifeCycle Management (PLM) Development of Virtual Client Development of Xapp Testing and Validation of PLM Testing and Validation of Weighing and Dispensing Qualification of PALPAL equipment Janssen Pharmaceutica Validation support lab equipment at Janssen Pharmaceutica Validation at Terumo Haasrode Implementation Network Qualification Plan at TiGenix Validation at Qualiphar Validation at Thrombogenics Validation At Shering Plough Validation at Alcon cGxP-trainings at Amgen Specialties: Designing, writing and implementing Quality Control Procedures for Highly regulated industries. Validation of quality critical software solutions, compliance to cGxP, FDA CFR 21 - part 11, GAMP, SDLC. Adobe Flash, Adobe Photoshop, Adobe Illustrator, Adobe Indesign, Adobe Flex
Projects related to Inspection, Filling, SIP/CIP, HVAC, Software
Freelance consultant CFR 21 part 11, CSV, GAMP, regulatory requirements for software development pharmaceuticals. Freelance designer website and GUI forum application. Freelance develloper c#, javascript, flash action script.
validation of software for FDA compliance (CFR 21 part 11, GAMP, ISO) for the pharma-industries