GxP QA-CSV & Digitalization Site Specialist

Mantu Manager Program; Beerse; Hybrid; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Job summary

Amaris Consulting, part of Mantu, seeks a QA-CSV/validation expert for a combined role in a GxP manufacturing site. You will provide independent QA-CSV oversight and practical validation support for execution systems while also acting as the Site Key User for Checklyst Manager, enabling digital checklists.

You will drive data integrity, manage access governance, support digital transformation, and coordinate onboarding across teams, ensuring timely record closure and compliant documentation.

Qualifications

• Experience in CSV, validation, quality assurance within a GxP-regulated environment.
• Practical lifecycle documentation, testing, change control, deviation management.
• Experience supporting system users, coordinating stakeholders, or acting as a key-user.
• Knowledge of CSV, SDLC, Annex 11, 21 CFR Part 11, GAMP 5 and data integrity.
• Understanding of risk-based validation, access controls, audit trails and data transfer.
• Experience with PLC/SCADA, industrial networks, and infrastructure monitoring.

Responsibilities

• Provide QA-CSV support for automation and visualization systems and shared services.
• Review validation deliverables, risk assessments, and change controls for impact on quality.
• Assess incidents and deviations, ensuring data integrity and validated state.
• Coordinate creation and testing of digital checklists in Checklyst Manager.
• Onboard new areas, govern user access, and support documentation and metrics.

Skills

QA-CSV

Validation

Digital systems

GxP

Risk assessment

System governance

Change control

User support

Active Directory

Education

Bachelor or Master in Engineering

Automation

Life Sciences

Tools

SIMATIC Logon

Active Directory

Checklyst Manager

SCADA/PLC

Job description

Amaris Consulting, part of Mantu, seeks a QA-CSV/validation expert for a combined role in a GxP manufacturing site. You will provide independent QA-CSV oversight and practical validation support for execution systems while also acting as the Site Key User for Checklyst Manager, enabling digital checklists.

You will drive data integrity, manage access governance, support digital transformation, and coordinate onboarding across teams, ensuring timely record closure and compliant documentation.