
Simon Heusler
s.heusler @axxos. ch
- Diploma in Biotechnology
- Occupational Health and Safety Specialist according EKAS
- Commercial Pilot (Australia and US)
- Various trainings in Quality Management and Six Sigma
Senior consultant at Axxos AG since 2010
Experience
- In total 17 years in the international pharmaceutical / MedTech industry in various roles
- 6 years as a consultant for Axxos AG
- 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
My personal Scrabble
