QA Quality Engineer / CSV

One of our client based in Schaffhausen is looking for a QA Quality Engineer / CSV who will be responsible for the lifecycle management of computerized systems in the manufacturing area, ensure data integrity, and maintain compliance with CSV and governance standards.*Please note we are looking for a fluent German speaker. Key Responsibilities:Manufacturing systems & Software Qualification:Ensure GMP and regulatory compliance for qualification activities of production systemsReview and approve qualification lifecycle documents (e.g., Impact & Risk Assessments, URS, interface qualification, Audit Trail review) for production systemsReview and approve procedures (WIs, SOPs) related to data integrity and lifecycle management of production systemsKNEAT experience (digital qualification tool)Data Integrity & Governance:Review and approve requirements for new software solutions and analyze data and process flows within the production environmentReview and ensure strategies for security, backup, and recovery for computerized production systems (e.g., databases)Approve archiving or migration of legacy system data as part of lifecycle managementInvestigate and assess data integrity issues and software non-conformities (NC, CAPA) in compliance with GMP and regulatory standardsCross-functional Collaboration:Support and coordinate teams (e.g., Production, IT, Quality Assurance) in the area of complaints to ensure seamless integration of production systems and data workflows.Ensure structured communication on requirements, system changes, and troubleshooting to improve interaction between teams.Requirements:M.Sc. in Natural Sciences, Computer Science, Engineering, or related field (Alternatively: Bachelor’s degree or equivalent vocational training combined with several years of relevant experience in a GMP environment)Proven work experience in GMP-regulated environments (preferably Quality Control)Experience with CSV qualification approach (ISPE standard)Fluent in German and basic spoken English skills (B1 or above desirable)Preferably hands-on familiarity with manufacturing systems qualification, CSV, SCADA, or virtualizationExperience with MES, OSI-PI, SAP, TrackWise, or TruVault is a nice to haveLocation: SchaffhausenDuration: until 31/12/2026Start date: Flexible*While we appreciate every application, please note that due to the high volume of responses, we may only be able to contact shortlisted candidates.**Please note that we can only consider EU/Schengen applications