QA-CSV Specialist
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Our client, a leading life sciences organization, is seeking a specialist to provide quality oversight and functional governance for computerized systems. The role combines independent QA-CSV validation support for manufacturing automation with the site-wide implementation of a digital checklist management system.
- Provide independent QA-CSV oversight for projects, changes, and operations within a GxP environment.
- Review and approve validation deliverables, including risk assessments, specifications, and summary reports.
- Assess changes, deviations, and CAPAs for impact on product quality and data integrity.
- Coordinate the digitalization of paper-based processes into controlled digital workflows and checklists.
- Govern user access and system roles to ensure compliance with business needs and segregation of duties.
- Monitor system metrics and ensure records are closed within acceptable timelines.
- Provide functional guidance and support to stakeholders across the site.
- Bachelor or Master degree in Engineering, Automation, Computer Science, or Life Sciences.
- 3+ years of relevant experience in CSV, validation, and quality assurance within a GxP-regulated environment.
- Practical experience with lifecycle documentation, change control, deviation management, and CAPA.
- Knowledge of SDLC, EU GMP Annex 11, US FDA 21 CFR Part 11, GAMP 5, and data integrity principles.
- Strong collaboration and organization skills with a solution-oriented approach.
- You are fluent in English.
Nice to Haves
- Experience with PLC, SCADA, industrial automation networks, or infrastructure monitoring.
- Familiarity with digital workflow or electronic form management solutions.
- Knowledge of Dutch.
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