Thomas Schoetzau
Qa Manager Combination Product @Bayer
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WORK HISTORY
Qa Manager Combination Product @Bayer
Berlin, DE
QA oversight in the area of combination products and medical devices- Leads for manufactured combination product launches and launched combination products design transfer and take over responsibility for keeping Design History File and Risk Management File up to date- Impact assessment for global regulations and standards with regard to local QMS and products, and adherence to directives/expectations to ensure patient safety and to protect the Bayer brand- Manages Risk Management and QAAs with RQUs and external Medical Device Legal Manufacturers- Change Managment activities for combination products and medical devices
EDUCATION
Humboldt-Universität zu Berlin
Diploma
Johann Wolfgang Goethe-Universität Frankfurt am Main
Doctor phil. nat.
SKILLS
ABOUT THOMAS SCHOETZAU
well experienced in devlopment of respiratory products, excellent understanding of development of combination products
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