Experience

• In total 17 years in the international pharmaceutical / MedTech industry in various roles
• 6 years as a consultant for Axxos GmbH
• 5 years as a Commercial Pilot in very remote areas (Australia, US) for a NGO.

Projects

• Implementation of process validation concepts in MedTech companies with up to 1000 employees
• Quality assurance of development projects regarding technical files, design verification, development of manufacturing process and process validation
• Development and Implementation of QM-Systems according EN 13485 up to successful certification within 3-6 months.
• Lecturing on various topics (Document control and traceability)
• Developing and managing processes and tools for the services of an Swiss- and EU Authorized Representative, including customer relationship management
• Internal auditing according ISO 13485 and support companies during (re-)certification audits

Skills

• Quality management (with focus on Validation, Quality Control, Regulatory Affairs, Vigilance and CAPA)
• Manufacturing processes, especially aseptic / biotechnological and plastic moulding processes
• Quality assurance, statistics, sampling and data analysis
• Lean Management
• Occupational Health and Safety for small to medium companies
• Spontaneous projects to achieve and/or maintain compliance
• Lead and coach change management processes
• Coding (R (statistics), Python, Excel, VBA)
• Installation, configuration and use of cloud-based software tools, e.g. of ERP and CRM-Systems, Document Control, Issue Tracking Tools, Websites
• Good knowledge of Linux, Libreoffice, Open Source projects, GIT
• Take off and land aircrafts (single engine piston) on short runways with up to 20% slope