Dipl.-Ing. Melanie Billens

o Manage and coordinate deviations, CAPA, Change Control, OOS-investigations and present in inspections. o Stability Studies / Analytical Method Validation/GxP-Studies review and approval. o QA Partner in FDA pre-license inspection for a new recombinant Hepatitis B vaccine.

o Manage Quality System improvement activities within and between the changing company structures o Preparation of Quality Manual, Site Master File, SOPs, deviation, CAPA, validation, qualifications. o Lead Auditor for GMP- and GLP-supplier audits (national and international). o Stability Studies – review and approval of protocols and reports. o Analytical Method Validation - review and approval o Trainer for GMP/GLP systems o QA expert/contact in national and international inspections

o Manage the GLP quality system. o Manage preparation and conduct of GLP inspections by local authorities. o Trainer for GLP quality system. o Co-auditor for internal GMP readiness inspection at Korea Green Cross Vaccine Corporation, Seoul, Korea. o Participation in the installation of a GMP Quality System for production of clinical samples (HepB vaccine) and Hansenula polymorpha cell banks

o Installation of a GLP Quality System, beginning from research grade. o GLP-trainer for employees. o Organize and manage initial GLP inspection by local authorities. o Organize and manage requirements by local authorities (S1/ S2 laboratories, health, safety)

Biotechnologie