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:
1. Carry out personnel, technical & people life cycle management of a IT QA & CSV team.
2. Act as a key contact person & all-rounder in the field of IT Quality Assurance & Computer Systems Validation.
3. Advise & support system owners, project managers or suppliers in the validation of computer systems according to internal & external GxP/GAMP specifications (eg in the field of production systems SW, SW development, MES or database systems).
4. Independently prepare the necessary documentation & execution of tests.
5. Support the continuous development of IT processes (eg further development of internal CSV processes or certification of IT service areas according to ISO : Information Security).
6. Act as a key contact person as a CSV expert for customers & audits.
7. Review & approval CSV & system documentation.
Your Skills:
8. At least 5 years of relevant professional experience including experience in IT Quality Assurance, Computer Systems Validation & Computer Software Assurance.
9. A sound knowledge of IT Security, GDPR & IT Systems & Infrastructure.
10. Experienced with Q-Systems (eg EU: Annex 11/FDA: 21CFR Part 11).
11. Ideally experienced in the Medical Technology Sector.
12. A knowledge of important IT Standards & Methods (eg ISO, ISO -2, ITIL) or ISO : QMS for Medical Devices.
Your Profile:
13. Completed relevant Scientific or Technical University Degree.
14. Strong communication skills, assertive & highly quality-oriented.
15. Fluent English & good German language skills (to at least B2 Level) are a mandatory requirement.