Cette offre d'emploi n'est pas disponible dans votre pays.
IT Quality Assurance & CSV Manager (German Speaking)
Helvetica PartnersGenève, Genève, CHIl y a plus de 30 jours
Description de posteAt least 5 years of relevant professional experience including experience in IT Quality Assurance, Computer Systems Validation & Computer Software Assurance. A sound knowledge of IT Security, GDPR & IT Systems & Infrastructure. Experienced with Q-Systems (e.g. EU : Annex 11 / FDA : 21CFR Part 11). Ideally experienced in the Medical Technology Sector. A knowledge of important IT Standards & Methods (e.g. ISO27001, ISO 80002-2, ITIL) or ISO 13485 : 2016 QMS for Medical Devices. Completed relevant Scientific or Technical University Degree. Strong communication skills, assertive & highly quality-oriented. Fluent English & good German language skills (to at least B2 Level) are a mandatory requirement.
Descriptif
We are currently looking on behalf of one of our important clients for an IT Quality Assurance & CSV Manager (German Speaking). The role is a permanent position based in Solothurn Canton & comes with some home office allowance.
Your Role :
- Carry out personnel, technical & people lifecycle management of a IT QA & CSV team.
- Act as a key contact person & all-rounder in the field of IT Quality Assurance & Computer Systems Validation.
- Advise & support system owners, project managers or suppliers in the validation of computer systems according to internal & external GxP / GAMP specifications (e.g. in the field of production systems SW, SW development, MES or database systems).
- Independently prepare the necessary documentation & execution of tests.
- Support the continuous development of IT processes (e.g. further development of internal CSV processes or certification of IT service areas according to ISO 27001 : Information Security).
- Act as a key contact person as a CSV expert for customers & audits.
- Review & approval CSV & system documentation.
Your Skills :
Your Profile :