QA Quality Engineer

Vor 5 Tagen

Schaffhausen, Schaffhausen, Schweiz Actalent Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

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 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

Location: Schaffhausen

Duration: until 31/12/2026

Start 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

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