Data Integrity & Validation Specialist

QbD Group

Henegouwen

On-site

EUR 65,000 - 95,000

Full time

10 days ago

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Job summary

QbD Group in Belgium is seeking a Data Integrity & Validation Consultant to support a major digitalisation program in the Life Sciences sector. You will map data and process flows, assess integrity risks, and drive remediation actions on shop floors.

Collaborative, with a strong focus on compliance with ALCOA+ and GxP principles. You will work on validation and continuous improvement of manufacturing systems, speaking with operators and engineers to translate real-world use into actionable

Qualifications

Master’s degree in a scientific or engineering field.
Solid knowledge of data integrity (ALCOA+, GxP, 21 CFR Part 11 / EU Annex 11).
Experience in DI assessments, gap analyses or remediation.
Life Sciences industry experience, manufacturing environment.
Fluent French with a good working level of English.

Responsibilities

Map and analyse process flows and data flows across manufacturing systems, from data generation to processing/reporting.
Assess data integrity risks along flows and identify gaps in controls (audit trails, access management, data review, backup).
Define and drive remediation actions and translate findings into practical recommendations.
Support validation and compliance of digital/automated manufacturing systems with data integrity as guiding thread.
Engage with operators and end users on the shop floor to capture reality and inform deliverables.
Take initiative, ask questions, and challenge assumptions; collaborate with QbD consultants and client stakeholders.
Where relevant, contribute to integration and implementation of our QbD quality management software at client sites.