Talent Pool - CSV (Computerised System Validation)

Description de l'entreprise

We secure the drug development while reducing time-to-patient for life-changing therapies.

Quality Assistance is a leading European CRO (Contract Research Organisation) exclusively focused on analytical sciences for innovative medicines. Based in Belgium, our company brings together 280 experts under one roof with over four decades of experience in delivering analytical excellence. Our single-site model enables agility and collaboration, while rigorous regulatory compliance ensures the highest standards of quality and reliability.

Our scientific experts provide GxP and security compliant analytical data that contribute to demonstrate quality, safety, and efficacy at every stage of drug development. From preclinical phases to regulatory approval and beyond, we provide the full range of analytical services required by the EMA and FDA regulations, acting as a trusted partner committed to excellence. Together, we shape the future of medicine through precision, reliability, and a shared commitment to improving patients’ lives.

Vos missions

Your next challenge
Ready 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 responsibilities
Here'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

Votre profil

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

Description de l'offre

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.

Here's why you'll love working with us.

• 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