QA Quality Engineer

vor 4 Wochen

Schaffhausen, Schweiz Actalent Vollzeit

Life Science Recruiter, specialised in Scientific 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. Key Responsibilities: Manufacturing systems & Software Qualification: Ensure GMP and regulatory compliance for qualification activities of production systems Review and approve qualification lifecycle documents (e.g., Impact & Risk Assessments, URS, interface qualification, Audit Trail review) for production systems Review and approve procedures (WIs, SOPs) related to data integrity and lifecycle management of production systems KNEAT experience (digital qualification tool) Data Integrity & Governance: Review and approve requirements for new software solutions and analyze data and process flows within the production environment Review 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 management Investigate and assess data integrity issues and software non-conformities (NC, CAPA) in compliance with GMP and regulatory standards Cross-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 virtualization Experience with MES, OSI-PI, SAP, TrackWise, or TruVault is a nice to have Duration: until 31/12/2026 Please note that we can only consider EU/Schengen applications. Seniority level Associate Employment type Temporary Job function Quality Assurance Industries Pharmaceutical Manufacturing and Biotechnology Research #J-18808-Ljbffr

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