Project Manager & Lead Auditor

Subject Area: Cleanroom Planning Lead

• Planning Lead for a new cleanroom for aircraft manufacturing processes
• Start-Up & commissioning and certification of the cleanroom

Subject Area: GMP Consultant & Construction planning

• Project lead for the design and planning of a new central hospital pharmacy including a production area to produce cytostatic agents
• Technical planning of building integration and process engineering of the plant design including basic & detail engineering
• Start-Up, commissioning and qualification of production equipment, e.g. clean rooms, general production equipment
• Validation of manufacturing processes, test methods and cleaning processes.
• Responsibility for the achievement of the “production authorization” (Herstellbewilligung) granted by Swissmedic

Subject Area: GMP Consultant & Construction planning

• Overall project lead for the design and planning of a new production area to produce cytostatic agents
• Technical planning of building integration and process engineering of the plant design including basic & detail engineering
• Start-Up, commissioning and qualification of production equipment, e.g. clean rooms, production roboteer, general production equipment
• Validation of manufacturing processes, test methods and cleaning processes.
• Responsibility for the achievement of the “production authorization” (Herstellbewilligung) granted by Swissmedic

Subject Area: Quality Management

• Integration of two satellite sites in Germany and Spain into the Quality Management System of the certificate holder in Switzerland.
• Harmonization of global quality processes across these three sites, sellout of these processes, process training and support.
• Hosting the certification audit for the Matrix Certificate as company representative.

Subject Area: Transfer of a reagent production plant

• Project lead for the transfer of a major reagent manufacturing plant from the United States to Switzerland
• Technical planning of building integration and process engineering of the plant design including basic & detail engineering
• Start-Up, commissioning and qualification of production equipment, e.g. clean rooms, filling lines, autoclaves and process control systems
• Validation of manufacturing processes and cleaning processes.