Computer System Validation(CSV) Expert:

Computer System Validation(CSV) Expert:

Proven Knowledge with / Certified
Validation of computer Systems (GAMP 3,4,5)
Agile Software Validation
Project Lead (Scrum Master) as well as validation lead

Experience with regulatory requirements (e.g.. AMWHV, FDA 21 CFR Part 11)
Support the Site with expertise to establish new digital technologies according to the regulatory requirements on the site
Process knowledge (Laboratory, Analytics, Instruments, Interface)
Overview about the IT-System-Landscape in laboratories (e.g. LIMS, ELN)
IT Knowledge (e.g. General concepts of Information Technologies, Interfaces)
Independent Workstyle
German (Business Fluent), English (Business Fluent)