Talent Pool - CSV (Computerised System Validation)

QUALITY ASSISTANCE S.A.; Henegouwen; On-site; EUR 55,000 - 85,000; Full time

Benefits offered by this job

Free fitness classes

Fresh fruit delivered

Up to 4 car washes per year

Lunch delivery

Job summary

Quality Assistance S.A. is expanding its team in Belgium to include a Computerised System Validation (CSV) Specialist. You will help keep laboratory computerised systems reliable, compliant and fit for purpose, working with QA, IT and operations.

You will define validation strategies, manage documentation (URS, DQ, IQ, OQ, reports), monitor suppliers, and support audits. Join a team of four CSV professionals reporting to the Team Leader and contribute to public health.

Qualifications

• Experience with CSV and lifecycle management of computerised systems.
• Familiarity with URS, DQ, IQ, OQ and validation reports.
• Knowledge of regulatory requirements including FDA 21 CFR Part 11, EU GMP Annex 11 and GAMP 5.
• Understanding data integrity principles in GxP environments.
• Experience with change control and validation impact assessments.
• Aware of audit and inspection requirements in regulated environments.
• Attention to detail in reviewing compliance and validation documentation.
• Ability to collaborate with QA, IT and Operations teams.

Responsibilities

• Define validation strategies for laboratory equipment computerised systems.
• Manage CSV documentation, including its preparation, review and execution, covering URS, DQ, IQ, OQ, validation reports and archiving records.
• Monitor suppliers during the installation of computerised systems.
• Ensure compliance with internal procedures throughout the system lifecycle.
• Contribute to internal audits through validation expertise and documentation support.
• Collaborate with IT, Quality Assurance and Operations teams to maintain project compliance.
• Assess system changes and determine their impact on validation status.
• Support users with system onboarding and troubleshooting.

Skills

CSV lifecycle

Validation docs

Regulatory knowledge

Data integrity

Change control

Audits & inspections

Cross-functional collaboration

Troubleshooting

Job description

Your next challengeReady to make a difference? Here's what awaits you.

As we continue to grow and prepare for future recruitment needs, we are building a talent pool of Computerised System Validation (CSV) professionals. By joining our talent community, you will be among the first candidates to consider when new opportunities matching your expertise become available.

As a Computerised System Validation (CSV) Specialist, you will help ensure that the computerised systems used within our laboratories remain reliable, compliant and fit for their intended purpose. These systems play an integral role in generating data that drive drug development, quality control and the release of medicines to patients.

You will join a team of four professionals dedicated to CSV and report directly to the Team Leader. Working closely with Laboratory, Quality and IT teams, you will help maintain the validated state of computerised systems throughout their lifecycle, ensuring data integrity and regulatory compliance across critical laboratory activities.

Your Key ResponsibilitiesHere's What You'll Be In Charge Of

• Define validation strategies for laboratory equipment computerised systems
• Manage CSV documentation, including its preparation, review and execution, covering URS, DQ, IQ, OQ, validation reports and archiving records
• Monitor suppliers during the installation of computerised systems
• Ensure compliance with internal procedures throughout the system lifecycle
• Contribute to internal audits through validation expertise and documentation support
• Collaborate with IT, Quality Assurance and Operations teams to maintain project compliance
• Assess system changes and determine their impact on validation status
• Support users with system onboarding and troubleshooting

Skills you'll need to bring

To Succeed In This Role, You'll Demonstrate

• Knowledge of laboratory computerised systems and their lifecycle management
• Understanding of validation documentation, including URS, DQ, IQ, OQ and validation reports
• Familiarity with industry best practices and regulatory requirements, including FDA 21 CFR Part 11, EU GMP Annex 11 and GAMP 5 (Good Automated Manufacturing Practice)
• Knowledge of data integrity principles in GxP environments
• Experience with change control and validation impact assessments
• Understanding of audit and inspection requirements in regulated environments
• Attention to detail in the review of compliance and validation documentation
• Ability to collaborate with Quality Assurance, IT and Operations teams
• Analytical approach to troubleshooting and problem-solving
• User-focused approach to onboarding and system support

Our commitment to you

From day one, you'll have access to a structured onboarding programme and continuous learning opportunities designed to strengthen your technical expertise in analytical sciences.

• Access to advanced laboratory technologies through significant ongoing investment
• A collaborative scientific culture where knowledge sharing is encouraged
• A workplace that supports work-life balance and long-term wellbeing
• The opportunity to contribute to projects with a direct impact on public health
• Everyday perks that make a difference: free fitness classes, fresh fruit, up to 4 car washes per year, and practical services like lunch delivery

Who we are

And why it matters

We are a Belgian contract research organisation (CRO) based in Thuin, partnering with pharmaceutical companies to deliver high‑quality analytical data in line with EMA and FDA standards.

Supported by a team of nearly 280 experts and continuous investment in advanced technologies, we help our partners move their projects forward through reliable, high-quality data. Every analysis contributes to maintaining the safety, quality and integrity required throughout the drug development process.

Joining us means becoming part of a collaborative environment where scientific expertise is valued, professional growth is encouraged, and every contribution helps advance public health, creating lasting value both for our projects and for your career.

Team up with us!

Quality Assistance provides the pharmaceutical industry with all the analytical services required by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) regulations for the development and marketing of innovative human medicinal products.

We will make you a key player in our team as we seek to develop the medicines of the future and to speed up people’s access to innovative drugs.