Involved and passionate
Years of experience and up-to-date knowledge
High demands on myself and my environment
I have been active as a quality professional for decades. I take that experience with me and combine it with a constant study of the latest developments. This is how I approach and face complex challenges before they become a problem.
Over the years I have gained extensive experience as a quality and regulatory manager in pharmaceutical automation. I have extensive experience with the validation of automated systems. The usability of the quality system for the employees or the validation for the customer is the most important. The required quality documentation must of course be clear, understandable and pragmatic so that end users can work with it pleasantly and error-free.
End of Paper
To be effective, quality must be widely supported and easily accessible. A paper system is therefore no longer of this time. The good news is that paperless validation is certainly possible. With the help of a good system that matches the quality ,document, risk and incident management system. I have already linked several quality systems
The best ideas, naturally
Because I am constantly working on quality, I set the highest standards for myself.
That is sometimes tiring for me and those around me. To keep a broad view,
I regularly seek out the tranquility of nature. I walk for hours with my dog
the forest and over the heath. And just when my head becomes empty, the best ideas arise.
View the summary of my resume
- ISO 13485:2016 (MDSAP) Lead auditor, (IRCA/CQI cert.)
- ISO 9001:2015 lead and internal auditor (IRCA/CQI cert.)
- ISO 9001:2015 setup, implementation, and integration with GMP
- ISO 27001:2013 lead auditor (IRCA/CQI cert. pending)
- ISO 27001:2013, requirements
- GMP; 21 CFR 21, 210, 211 Eudralex vol.4, EU-ADD guidelines
- Internal and supplier audit (lead-auditor)
- Software validation (GaMP 4+5)
- Hardware qualification GMP (Annex 15)
- Validation lifecycle documentation
- Material certification process (Foodcontact EU en USA, USP, Ph. Eur),
- Process risk assessment (FMEA)& risk mitigation
- Training and workshop GMP and CSV
You can find my resume on LinkedIn
Because I am constantly working on quality, I set the highest standards for myself. That is sometimes tiring for me and my environment. In order to maintain a broad view, I regularly seek out the tranquility of nature. I then walk for hours with my dog through the forest and over the heath. In this tranquility often the best ideas arise.