Winterthur, Zurich, Switzerland
Quality assurance and Quality management professional 2.5 years experience as consultant to the pharmaceutical industry: QP assistant, Penicillin production, oral and sterile dosage forms mock auditing Complaint Management, QA-trouble Shooting, FDA Projects, Inhalers, Solids, API, CMO Cleaning Validation 9 years experience in leading cGMP API, intermediate and starting materials/raw materials production in a multpurpose plant, responsible for all cGMP activities (2001-now) Lead of accreditation to ISO 17025 (2007 -now) Lead of accreditation to ISO Guide 34 (2007) Lead to certification to ISO 13485 (2010) and of course ISO 9001 (since the beginnnig) before that: two years as assistant to production manager in the cGMP chemical production vast auditing experience (Europe, China, India) successfull experience in process improvement Specialties: Specialist of Quality systems, API production, chemical production, management of teams Generalist in all activities in a chemical production plant
projects: as a contract QP in Austria and GDP expert in CH
Site implementation of Regional Optimization Changes at Buchs Site Business Transfer Champion