Paul Scholten

I am an IT professional with 25 years of experience ranging from hardware and infrastructure to system development and quality assurance. I work as a compliance expert in project and service management assurance, related to Pharmaceutical quality. I act as a lead auditor in internal and external audits. I have proven ability to lead computer validation activities in a global environment. My colleagues describe me as structured, pragmatic and a person with the ability to simplify complex situations (enabler). Personally, I see myself as a “self-starter” capable of autonomous working, focused on delivery. Specialties: * Lead auditor ISO9001:2008 (IRCA certified) * Computer Validation (GAMP5) * ISO 9001 Quality Systems implementation * Regulations (e.g. GCP, GMP, GLP, SOX, ER/ES) * EDMS * Change Management (organization) * Developer of SOPs and processes * Security, Data Privacy * COBIT5