Description
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.
- At 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.
Your Profile:
- 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.
