michel kliaving

-Science Related Expert for Microbiology for definition and implementation of critical microbial control strategies to optimize the microbiological safety of these productions in a cost-effective way -Responsible for interactions with health authorities in both follow-up of regulatory submissions and audits. -Responsible for risk analyses related to deviations of manufacturing processes, -Representative for the Swiss authorities of the biosafety of the site.

Team: 2 managers. 1supervisor, 4 GMP Compliance Officers, 13 analysts, 3 samplers. Lab activities: Support for R&D developments and responsible for all routine monitoring & testing activities • Responsible for the development, validation and implementation of an alternative method (Chemscan RDI) reducing these release times from 7 days to 2 • SMEi for interactions with health authorities in both registration processes and audits

Team (working in 2 shifts): 2 serpervisors, 3 coordinators, 16 analysts and 10 samplers Lab Activities: Product testings, LAL testings, Mycoplasms detection, Microbial identifications & Environmental monitoring of the production site. • Leadership for the design of the new lab extensions , the staffing of the lab and the up-grade of the Microbiology lab to FDA standards. • SME for the FDA inspection in 2003 (Agreement obtained )

Team: 1 serpervisors, 1 assistant, 8 analysts and 1 technician. Lab activities: API/raw materials testing, products testing, Microbial identification, biological assays, sterility testing, environmental monitoring. • Responsible for the lab transfer to new locations (without lab activities reductions) • Responsible for the proposal and the qualification of a new rapid method for microbial testing (Chemscan RDI) • Technical support for suppliers audits