Tanja Mertens

• Non-conformity handling & CAPA management • Document change management • QMS management according to ISO 13485:2016, MDSAP und MDR • Trend analysis • External and internal audits • Quality trainings

• Quality check of all Trial Master File documents • Tracking, scanning, coding, photocopying and filing study documents • Preparing, distributing, storing and archiving study files • Supporting preparation of study-specific documents • Compliance with applicable ICH-GCP guidelines, local regulatory requirements and SOPs • Completing routine administrative tasks in a timely manner (e.g. timesheets, metrics)

Postgraduate traineeship in pre-clinical research in the area of neurodegenerative and lipid disorder diseases. • Set up, management and evaluation of two pre-clinical projects • Working independently and with responsibility • Work within tight deadlines • Development and evaluation of in vitro models

• Participation in international conferences • Presentation and teaching skills • MS/MS, SILAC labeling, FA labeling and mass spectrometry data analysis • Immune assays, work with multimode plate reader and appropriate data analysis • Cell culture of primary cells, molecular biology, qRT-PCR, FACS

• International working- and living experiences • Work on function of MTCH2 in the skeletal muscle system • Cell culture of primary muscle cells, in vivo work, biochemical assays, FACS

Independent working on cell-surface display of lipolytic enzymes, plasmid DNA preparation and cell transfection as well as implementation of biochemical assays.

Molekular medicine, dermatology, biochemistry, cell biology