Florian Winner

Background

About Florian Winner

Business Upper Austria, the business agency of the Upper Austrian government, is an innovation driver and a partner for location development & settlement of companies, cooperation and public funding advisory services. As a one-stop shop, we assist domestic and foreign companies by supplying tailor-made services and support them from the initial business idea through to market success. For more than 15 years I worked for Greiner Bio-One Diagnostics GmbH (former Lambda GmbH) in Rainbach i. Mkr, a manufacturer and developer of outstanding high-tech in-vitro-diagnostic devices (IVD) for the molecular detection of viruses and bacteria in human, biologicals and food. More than ten years I was the managing director of Greiner Bio-One Diagnostics GmbH. I was responsible for all commercial, organizational and strategical affairs of the company and for the operational business of manufacturing, quality control, quality management and R&D. In my period as a managing director, the company grew from 11 to 54 employees. For more than 8 years I was head of the quality management department. In this period I established and implemented a quality management system (QMS) according to ISO 13485, ISO 9001 and partially GMP, managed the primal certification of the QMS by notified bodies and authorities, was leading auditor when approving our suppliers and also accompanied GMP audits by our pharma-customers. As a project manager in R&D I was also responsible for the development of several diagnostic products, for example ParoCheck(R), a diagnostic kit fpr the detection of 20 periodontal bacteria, CarnoCheck(R), a diagnostik test kit for the detection of 8 animal species in food and feed and CytoInspectTM. The CytoInspectTM assay utilises DNA microarray technology for detection and identification of mycoplasmas in vaccines and biologicals. It is validated according to Ph. Eur. mono-graphs 2.6.7, 2.6.21 and Ph. Jap. chapter 9.