MSc in Chemical Engineering with long experience from the pharmaceutical industry (late phase pharmaceutical development) and from the packaging industry.As Senior Scientist at the Analytical Science department at AstraZeneca I have been the responsible for pharmaceutical projects in late phase. I am therefore experienced in preparing advanced regulatory documents (e.g. NDA, JNDA, MAA, CTA), handling Quality Assurance issues, validation and development of medical device, analytical chemistry etc. During more than 10 years I was also a member of a GMP-coordination group at the department where we worked with quality issues at the laboratory in close connection with the QA- department. As a Development Engineer at Tetra Recart I have been involved in Test Method Development, for packaging material, documentation and validation. At TetraPak I also worked at the Material Analaysis department where I performed analyzes on e.g. packaging materials and base materials. Together with a project manager I was also responsible for the development and implementation of a new LIMS system at the department. Today I work as Laboratory Manager/ Senior Inhalation Analyst at Emmace Consulting AB in Lund. Main areas are Inhaler Performance Testing, Aerosol measurements/ characterization, Testing of aerosol devices with patient realistic profiles, and Development of Medical devices and Pharmaceutical formulations. Specialties: Regulatory documentation for registration files (MAA, NDA)Quality Assurance (e.g. GMP coordination, Documentation)Analytical Chemistry (Aerosol technology, impactor measurements etc)Aerosol analysisProduct developmentMethod developmentMedical device developmentPackaging materialValidationRegulatory documentation (e.g in e-CTD format)InhalationHPLCAutomationGMPPolymersRheologyLIMS development
Listed skills include Analytical Chemistry, Gmp, Validation, Pharmaceutical Industry, and 16 others.