Dr. Ingo Florian

Continually develop Quality Statement in line with the overall Phoenix Mission statement Set up an adherence system to ensure consistent implementation in each of the Locations Create and manage the Quality Management Team, including all local Quality Managers Act as escalation point for quality related issues Actively represent Phoenix in relevant associations Connect to EMA and National Authorities as needed

Set-up and review the strategy for the Quality support of the independent Associate Companies (IAC’s), Joint Ventures (JV’S), Mundipharma Licensees (ML’s) and third parties across the European Region, ensuring inspections readiness for pharmaceutical products and medical devices.

Head of department and overall responsibility for Germany and CEEC

- Installation & maintenance of QA-and PhV-Systems in the CEEC - Warehouse audits acc. GDP - passing of local authority inspections, ensuring inspection readiness - supporting medical device business

- Internal and external audits - Support of the development of medical devices - Conformity assessment procedures of medical devices acc. 93/42/EEC - Safety officer for medical devices acc. German medical device law (§30 MPG) - Training of employees concerning GMP, GCP, medical device law and European guidelines - Notified person for external audits acc. ISO 13485:2003 - Responsible for the successful upgrade from 13485:2000 to 13485:2003 - Implementation of PAT & Quality Risk Management

Beratung und Analyse von Mikrostrukturanalysen (spez. Oberfläche; Porenverteilung etc.)

Promotion and Bearbeitung eines EU-projects

Mirkostrukturanalytik, Referenzmaterialien