Maria Abbe Nilsson
Senior Quality Assurance Specialist
Sweden
Kalmar County
Biotechnology
Design Control, CAPA, ISO 13485, ISO 14971, FDA, Medical Devices, Quality System, Quality Assurance, Validation, Medical Device Directive, Change Control, Regulatory Affairs, Pharmaceutical Industry, GMP, V&V, 21 CFR Part 11, R&D, Quality Auditing, CE marking, Quality Management
Experience
Senior Quality Assurance Specialist
RepliGen Sweden AB
Lund, Sweden
Quality Assurance Specialist
Atos Medical AB
Project QA in R&D projects. Design Control, Risk Management Quality Assurance, Quality System, GMP Complaint handling Regulatory Affairs, Global Product Registrations Internal Auditing ISO 13485, QSR 820, CMDCAS (Canada)
QA/RA Project Manager
Gambro
QA/RA Project Manager in different R&D projects QA knowledge of drugs and of medical devices Design control, Risk Management, Supplier qualification, Quality systems
Laboratory Engineer and Quality Manager
Ferring Pharmaceuticals
Pharmacology Research 1988-1996 (In vivo and in vitro studies) Quality Manager 1996-2001 Ferring Pharmaceuticals (GMP, Quality systems, aseptic production, authority inspections MPA, FDA, complaints and recalls)
Education
Lund University
Maria Abbe Nilsson's Contact Information
Phone
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