QA-CSV & Digitalization Site Key User (Remote)

MANTU GROUP SA

Beerse

Remote

EUR 70,000 - 100,000

Full time

3 days ago

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Benefits offered by this job

Health insurance

Remote work option

Meal vouchers

Time savings account

Referral bonus

Job summary

Mantu Group SA seeks a QA-CSV Professional to provide independent oversight in a GxP environment. You will validate execution systems and act as site lead for Checklyst Manager, driving digital transformation and data integrity across the site.

The role requires 4–7 years in CSV/validation, strong documentation discipline, and ability to coordinate across multiple teams. Fluent English is required; Dutch is a plus. Hybrid work and competitive benefits are offered.

Qualifications

Experience in CSV, validation, quality assurance, digital systems within a GxP-regulated environment (4–7 years).
Lifecycle documentation, testing, change control, deviation management, and maintenance of the validated state.
Experience supporting system users, coordinating stakeholders, or acting in a key-user or system-governance role.
Knowledge of CSV, SDLC, EU GMP Annex 11, US FDA 21 CFR Part 11, GAMP 5, and data integrity expectations.

Responsibilities

Provide QA-CSV oversight for PLC/SCADA-based automation and visualization systems.
Review and approve validation deliverables and traceability documentation.
Assess changes, incidents, deviations, and CAPAs for impact on quality and data integrity.
Coordinate creation, testing, and documentation of new digital checklists in Checklyst Manager.
Onboard new areas and ensure readiness for adoption; govern user access and provisioning.