Basel Area, Switzerland
Global Quality Manager at Bayer HealthCare
Pharmaceuticals
Education
University of Applied Sciences, Lemgo 2003 — 2008
Dipl.-Ing. (FH)
Experience
Takeda GmbH October 2013 - December 2014
Nycomed GmbH (until Nov 2012) / Takeda GmbH September 2008 - September 2013
Bayer Schering Pharma AG October 2006 - November 2007
Varta Microbattery GmbH July 2004 - September 2004
Schwarzkopf & Henkel Production Europe GmbH & Co. KG February 2004 - March 2004
Skills
Risk Analysis, Microsoft Office, 21 CFR Part 820, GMP, Regulatory Compliance, Supplier Qualification, Batch Record Review, LIMS, SOP, ISO 14971, ICH Q8, Q9, Q10, Q11, Self-inspections, Authority Inspections, Technical Development, IMP, EDMS, Medical Device Directive, Deviation Management, Quality Assurance, Medical Device R&D, Regulatory Affairs, Change Control, Contract Manufacturing, Regulatory Submissions, Pharmaceutical..., Quality Management..., GxP, FMEA, Combination Products, ISO 13485, Quality Agreements, Document Management, Process Improvement, CMC, Quality by Design, Medical Devices, Clinical Trial Supplies, Technical File / Design..., Training, Inspection Readiness, Design Control, Quality Auditing, Risk Management, Management Review, Quality Management, Pharmaceutical Industry, Vendor Management, SharePoint, CAPA, Project Management