QA-CSV Specialist & Site Key User

Pauwels Consulting; Beerse; On-site; EUR 70,000 - 95,000; Full time

Job summary

Pauwels Consulting seeks a QA-CSV Specialist to provide independent oversight for computerized systems within a GxP environment. You will validate changes, assess CAPAs, and drive digital checklist management across the site. Strong SDLC knowledge and fluency in English are required.

The role emphasizes quality assurance, risk assessments, and maintaining data integrity while coordinating with stakeholders on validated digital workflows and system access governance.

Qualifications

• 3+ years of experience in CSV validation and quality assurance within a GxP-regulated environment.
• Experience with lifecycle documentation, change control, deviation management, and CAPA.

Responsibilities

• 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.

Skills

QA-CSV oversight

GxP experience

Validation

Change control

CAPA

Data integrity

SDLC knowledge

Education

Engineering

Automation

Computer Science

Life Sciences

Job description

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.