IT Quality Assurance & CSV Manager (German Speaking) - SEM59662 - Helvetica Partners Toggle navigation FR EN DE Contactez-nous MENU Opportunités Services Industries Candidats Clients Nous Contact S'enregistrer Svp Login Se souvenir de moi Mot de passe oublié ? Connexion IT Quality Assurance & CSV Manager (German Speaking) - SEM59662  Retour en arrière IT Quality Assurance & CSV Manager (German Speaking) - SEM59662 #17199199 | 19 April, 2024 POSTULER Localisation Solothurn Canton, Soleure, Suisse Type de poste Poste fixe Nombre d'années requises de 6 à 10 ans Langues requises Formation Compétences requises Categories Quality Insurance Engineer IT Manager Quality control Quality 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:   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.   POSTULER Contact Adresse Helvetica Partners Sàrl Chemin des Aulx 5, 1228 Plan-les-Ouates, Geneva Switzerland Téléphone Tel: +41 22 794 35 14 Fax: +41 22 794 35 15 Courriel [email protected] Demandez qu'on vous rappelle © Copyright 2024 - Helvetica Partners Terms & Conditions Crée par 8Ways Media SA