Lena R Huerlimann has 18 years QC/QA/RA experience in pharmaceuticals and medical devices. Her auditing expertise includes GMP/GLP/GCP environments, as well as ISO 13485/ISO 9001/ISO 15378 facilities.
She has worked for Notified Bodies (NB) as a Lead Auditor. As an RA Consultant and GMP/GLP/ISO auditor, she currently performs contract work for registrars, NBs and private companies, and audits critical component manufacturers, final product suppliers and warehouses.
Her language proficiency includes written and spoken skills in English, Spanish and German.