My work style can best be described as rational and consensus-based. The areas and related competences are described below.

Have a look at my LinkedIn page for an up-to-date profile.

• Create Validation Plans
• Setup (Requirements) Specifications
• Create Installation Qualification Testing Plans & Reports
• Draw up Operational Qualification Testing Plans & Reports
• Performance Qualification Testing Plans & reports
• User Acceptance Testing Plans & Reports
• Compose System Standard Operating Procedures
• Validation Summary Report

• Monitor and maintain Controlled State of validated systems
• Periodic Reviews
• Change Management
• Deviation Management
• CAPA handling
• Compose Standard Operating Procedures & Working Instructions
• Coordinate Maintenance & Repair activities
• Maintain Life Cycle Documentation
• Execute Root Cause Analysis
• Partner with Quality Department

• Setup Validation Framework
• Review Validation Documentation
• Approve Validation Documentation
• Support Root Cause Analysis
• Review and Approve Changes, Deviations
• Progress monitoring of Changes, Deviations and CAPA’s

• Working experience: > 20 years
• Regulation experience: GMP, GLP, FDA 21 CFR 11
• Guideline experience: GAMP, OECD
• Areas of expertise: Computerized Lab Systems, Stand-Alone Laboratory instruments, production systems (sterile- and non-sterile)
• Career: Organon, Schering-Plough, Banner PharmaCaps (Patheon Softgels) MSD, PharmaCell (Lonza), Rescop B.V.