Consultant, Pharma Biotech

Email: pharmamail@nsf.org
Phone: +44(0)1751 432999
Country: Germany

Klaus von Jan has more than 20 years of operational experience in the pharmaceutical, biotech, vaccine and API industries. He has experience handling FDA inspections and spent a significant amount of time in the U.S. as a business lead for the implementation of a global electronic document management system (Livelink) and a deviation management system (TrackWise).

Dr. von Jan is a certified ISO 9001/13485 auditor for DQS.  He has acted as Responsible Person for a Switzerland based company, and has worked as Head of Quality Assurance at Millipore BioSyntech GmbH and as Director of Quality Assurance at Chiron Vaccines.

His areas of expertise include:

  • Quality assurance
  • Regulatory and GMP processes and procedures
  • Design and implementation of QMS in accordance with European standards
  • Aseptic manufacturing
  • Biotechnology, vaccines, APIs and computer software applications
  • GMP and QA training
  • Quality system auditing, mock inspections and gap analysis for compliance
  • Inspection readiness for EU and FDA inspections
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