CSV/IT Quality Specialist – Hybrid & Global Compliance

OneSource Consulting; Geel; Hybrid; EUR 60,000 - 90,000; Full time

Job summary

OneSource Consulting seeks a CSV/IT Quality Specialist to lead quality, compliance and validation of IT systems in a regulated, international setting. You will ensure GxP compliance, audit readiness and robust documentation across the system lifecycle.

Key responsibilities include validation strategy maintenance, risk assessment, change control and collaboration with quality managers, system owners and business leads. Fluency in Dutch and English is required.

Qualifications

• Proven experience with CSV and IT Quality in a regulated environment (GxP).
• Strong knowledge of GAMP 5, 21 CFR Part 11, ICH Q10 and EU Annex 11.

Responsibilities

• Monitor and maintain validation strategies and documentation for IT systems.
• Perform risk assessments for digital solutions and ensure high quality standards.
• Draw up validation reports and manage validation files from A to Z.

Skills

CSV/IT Quality

GxP compliance

Validation

Documentation management

Risk assessment

Audit readiness

GAMP 5 / 21 CFR Part 11 / ICH Q10

ALCOA+ data integrity

Dutch & English communication

Tools

Quality documentation system

Ticketing system

Job description

OneSource Consulting seeks a CSV/IT Quality Specialist to lead quality, compliance and validation of IT systems in a regulated, international setting. You will ensure GxP compliance, audit readiness and robust documentation across the system lifecycle.

Key responsibilities include validation strategy maintenance, risk assessment, change control and collaboration with quality managers, system owners and business leads. Fluency in Dutch and English is required.