CSV/IT Quality Specialist

NTek Software Solutions; Brussel Hoofdstad; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

NTek Software Solutions in Belgium seeks a CSV/IT Quality Specialist to lead IT quality, validation and GxP compliance for client systems in a regulated setting.

You will drive documentation, audits, SOPs and change approvals, acting as SME for validation methodologies and process optimization across IT platforms.

Qualifications

• Proven experience with CSV and system lifecycle methodologies.
• Strong knowledge of GAMP 5, 21 CFR Part 11, ICH Q10 and EU Annex 11.
• Understand, optimize, and document processes.
• Experience with deviation, CAPA, change control processes and documentation management in a regulated (GxP) environment.
• Knowledge of risk-based validation and data integrity principles (ALCOA+).
• Experience with quality documentation systems and/or ticketing systems is a plus.
• Accurate, compliance-oriented and independent work.
• Fluent in Dutch and English.

Responsabilités

• Maintain validation strategies and documentation for IT systems.
• Perform risk assessments for digital solutions and ensure quality standards.
• Draw up validation reports and manage validation files from A to Z.
• Collaborate with quality managers, system owners and business owners.
• Manage IT procedures (SOPs) and manuals in the quality documentation system.
• Update documentation, handle change requests, archive correctly.
• Lead development and maintenance of digital processes.
• Monitor KPI reporting and IT systems overview.
• Support GxP audits and inspection readiness.
• Assist supplier audits and act as validation SME.

Connaissances

CSV (Computerized System Validation)

GAMP 5

21 CFR Part 11

ICH Q10

EU Annex 11

Risk-based validation

ALCOA+ data integrity

Quality documentation systems

Change control & CAPA

Documentation management

Dutch & English fluency

Outils

Ticketing systems

Description du poste

Work Regime: Full-time assignment, onsite 2 to 3 days a week

Languages: Dutch and English

Deadline: ASAP

Position Overview

For Client (Geel), we are looking for a CSV/IT Quality Specialist. The client indicates that the emphasis is on the broader QA whole and not just on CSV. They are mainly looking for someone who can handle documentation well and can help with audits, SOPs, reviews, change approvals, ...

Are you a driven expert in Computerized System and IT Quality, do you have a strong IT affinity, and do you want to play a key role in an international, innovative environment? Then this challenge is for you!

As a CSV/IT Quality Specialist, you are the driving force behind the quality, compliance and validation of our IT systems and processes. You will work in a dynamic, regulated environment where your expertise directly contributes to the reliability and security of our digital infrastructure and operations.

You are the central point of contact for GxP compliance (GAMP 5, 21 CFR Part 11, ICH Q10) and audit readiness.

Responsibilities

System Lifecycle & Validation

• You monitor and maintain validation strategies and documentation for our IT systems.
• You will perform risk assessments for digital solutions and ensure that they meet the highest quality standards.
• You draw up validation reports and manage validation files from A to Z.
• You work closely with quality managers, system owners and business owners.

Process and Documentation Management

• You manage IT procedures (SOPs) and manuals in the quality documentation system.
• You ensure timely updates of documentation, you handle change requests, and ensure correct archiving of documentation.
• You are responsible for optimizing the processes and associated procedures; you take the lead in developing, formalizing (in SOP or manual) and managing (maintenance) Digital processes.
• You monitor and verify the correct execution of the procedures, you oversee the correct and timely execution of periodic reviews and tasks.
• You maintain learning curricula and make adjustments based on changes to global and local procedures.

Change Control & Compliance

• You are an expert in the change control processes and you ensure the creation, correct execution, compliance review & approval of all changes.
• You represent IT in weekly change meetings and closely follow up on actions.
• You carry out impact analyses in the event of changes and monitor compliance with internal procedures.

Deviation and CAPA Management

• You are an expert in the deviation and CAPA processes and, in consultation with the IT experts, you ensure creation, correct execution, compliance review & approval.

Audit Support & Inspection Readiness

• You are the first point of contact for GxP audits and inspections by regulators.
• You prepare validation files and audit documentation and ensure that everything is inspection-ready.
• You support supplier audits and act as a subject matter expert for validation methodology.

Periodic Tasks

• You maintain the IT planning and provide KPI reporting.
• You manage the official overview of all computer systems and the IT supplier list.

Required Skills & Experience

• Proven experience with Computerized System Validation (CSV) and system lifecycle methodologies.
• Strong knowledge of GAMP 5, 21 CFR Part 11, ICH Q10 and EU Annex 11.
• You like to understand, optimize, and document processes.
• Experience with deviation, CAPA, change control processes and documentation management in a regulated (GxP) environment.
• Knowledge of risk-based validation and data integrity principles (ALCOA+).
• Experience with quality documentation systems and/or ticketing systems is a plus.
• You are accurate, compliance-oriented and enjoy working independently.
• You communicate fluently in both Dutch and English.

Additional Assets

• Knowledge of risk and compliance frameworks within digital/IT environments.
• Experience with SaaS validation and cloud-based systems.
• Certification in GAMP 5 or CSV.
• Experience with audit and inspection readiness.