Simon Heusler

s.heuslernoSpam@axxos.noSpamch

 

  • 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 GmbH since 2010

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

My personal Scrabble