QA-CSV & Digitalization Site Key User (F/M/X)

Amaris Consulting | Part of Mantu; Beerse; On-site; EUR 65,000 - 90,000; Full time

Job summary

Amaris Consulting | Part of Mantu in Belgium is seeking a QA-CSV specialist to oversee validation and digital systems within a GxP manufacturing environment. You will serve as independent QA-CSV oversight for execution systems and act as Site Key User for Checklyst Manager, driving digital transformation, data integrity, and compliant records across the site.

The role requires collaboration with cross-functional teams, risk-based validation, change control, and timely closure of records, with

Qualifications

• 4–7 years’ experience in CSV, validation, QA/quality assurance in a GxP-regulated setting.
• 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 application-support role.
• Solid knowledge of CSV, SDLC, EU GMP Annex 11, US FDA 21 CFR Part 11, GAMP 5, and data integrity expectations.
• Understanding of risk-based validation, electronic records and signatures, access controls, audit trails, and data transfer.

Responsibilities

• Provide QA-CSV oversight for PLC/SCADA-based systems and automation networks, and for digital checklists in Checklyst Manager.
• Review and approve validation deliverables and traceability documentation.
• Assess changes, deviations, CAPAs for impact on product quality and data integrity.
• Coordinate onboarding, testing, documentation, access governance, and metrics for digital workflows.

Skills

CSV validation experience

Quality assurance

Digital systems

GxP environment

English fluency

Education

Bachelor/Master in Engineering or Life Sciences

Tools

SIMATIC Logon

Active Directory

Checklyst Manager

GAMP 5

Job description

Job Description

Join our team and start a new adventure in an international and dynamic environment, where you will be able to fulfil your career expectations in a fast-growing organization.

Job Description

Join our team and start a new adventure in an international and dynamic environment, where you will be able to fulfil your career expectations in a fast-growing organization.

In this combined role, you will support two complementary areas within a GxP manufacturing environment. 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, a core digitalization system supporting the transition from paper to controlled digital checklists. This position is critical to ensuring robust quality assurance, data integrity, and digital transformation across the site.

Your missions

• Provide QA-CSV support for PLC and SCADA-based automation and visualization systems, particle and environmental monitoring systems, and automation network shared services (including Active Directory, access and policy management, backup and restore, patching, antivirus, and infrastructure monitoring).


• Review and approve validation deliverables, including assessments, plans, requirements, risk assessments, specifications, test documentation, traceability, and summary reports.


• Assess changes, incidents, deviations, defects, and CAPAs for impact on product quality, patient safety, data integrity, and validated state.


• Apply a pragmatic, risk-based approach focused on critical functions, data, interfaces, and controls.


• Assess controls for access management, audit trails, electronic records and signatures, time synchronization, backup, restore, retention, and data transfer.


• Support data-flow mapping, inspection readiness, periodic reviews, and elevate material quality risks as needed.


• Coordinate and oversee the creation, configuration, testing, and documentation of new digital checklists in Checklyst Manager.


• Ensure new or changed checklists are reviewed, tested, approved, and released before operational use.


• Onboard new areas and teams, align on intended use, responsibilities, training, and readiness for adoption.


• Govern user access, support timely provisioning, modification, and removal of access, and periodically review roles and responsibilities within the system.


• Provide first-line functional guidance to users, authors, reviewers, and area representatives, and coordinate escalation of system issues.


• Run and review system and process metrics, identify overdue or non-compliant records, and coordinate follow-up actions.


• Ensure records are controlled, monitored, and closed within acceptable timelines, escalating delays as necessary.


• Support continuous improvement, standardization, and site governance.

Your profile

• Experience in CSV, validation, quality assurance, digital systems, automation, or computerized systems within a GxP-regulated environment (typically 4-7 years)


• Practical experience with 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, application-support, or system-governance role


• Good working knowledge of CSV, SDLC, EU GMP Annex 11, US FDA 21 CFR Part 11, GAMP 5, and recognized data integrity expectations, including PIC/S guidance


• Understanding of risk-based validation, electronic records and signatures, access controls, audit trails, backup and restore, interfaces, and computerized-system documentation


• Experience with PLC/SCADA, industrial automation networks, particle monitoring or shared automation services


• Experience with Active Directory, SIMATIC Logon, backup and restore, data transfer or infrastructure monitoring


• Experience with digital checklist, workflow, electronic form or calculation-management solutions


• Experience with data-flow mapping, data integrity risk assessments, access governance, metrics or inspection support


• Academic background: Bachelor or Master degree in Engineering, Automation, Computer Science, Life Sciences, or a comparable technical or scientific discipline


• English fluent; Dutch is a strong plus


• You demonstrate the ability to translate business processes and paper-based activities into clear, controlled digital workflows and checklists, and to coordinate onboarding, testing, documentation, access governance, metrics, and timely record closure across multiple teams

What we offer

Joining Amaris isn't about joining a company where you simply wait patiently for a vacancy to arise. It's about becoming part of an environment where your performance directly drives your career progression.

In practical terms, here's what this means for you on a