I am a computer system validation engineer. In recent years with Yxion, Rescop and Atos, I have worked in validation projects for principals in the medical devices, the pharmaceutical and high-grade food industry. In these projects I used the GAMP5 guidelines. I have worked on validation packages containing a complete set of validation documents having a URS document, an FS document, a DS and configuration document, an Installation document, functional test documents and process test documents. I also participated in test teams writing and executing functional and process test scripts. As part of the validation of systems, we often did 21 CFR Part 11 assessments. I am well capable of acting as SME member in CSV projects.
Aside from a strong knowledge and experience with computer system validation based on GAMP5 I also acquired knowledge of the new way of thinking of the FDA as far as CSV is concerned which they laid down in their Case for Quality program. They called this new approach to validation Computer Software Assurance
I have a strong background GMP and quality assurance. I have implemented a quality assurance system based on ISO-9001 that contained elements of current GMP. For my role as quality assurance manager I did a GMP training with the Center for Professional Advancement dealing with the production of pharmaceutical APIs.
During my employment with Atos and Rescop I have participated as LIMS consultant in multiple application management and data migration and implementation projects in which different LIMS systems were involved. Thereby, I gained experience with Simatic IT Unilab 6.1 and 6.4 from Siemens, Samplemanager 10 from Thermo Fisher and Labware 7.0 from Labware. In a similar role with Johnson & Johnson, Janssen Pharmaceutica, I gathered user requirements for the implementation of clearance experiments in the IDBS Electronic Lab Notebook. With Galapagos I was the business project manager for the selection and implementation of an ELN for the medicinal chemistry groups. We did a selection trajectory in which I collected the user requirements of the system in workshops with stakeholders. After the selection of the system I had the role of business project manager for the implementation of the system.
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