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Scope

To support our continuous growth and ensure compliance of computerized systems with regulatory requirements, we are currently looking for a CSV Specialist (Computerized System Validation) Specialist.

Your mission

You will join a team of 3 professionals dedicated to CSV and you will report directly to the Team Leader.

Main Responsibilities:

  • Define and implement validation strategies for laboratory equipment computerized systems
  • Draft, approve, and execute CSV documentation: URS, DQ, IQ, OQ, validation reports, archiving, etc.
  • Monitor suppliers during the installation of computerized systems
  • Ensure compliance with international regulations (FDA, GAMP) and internal procedures
  • Participate in internal audits
  • Collaborate with IT, Quality Assurance and Operations teams to ensure project compliance
  • Manage changes and assess their impact on system validation
  • Provide user support for computerized systems during onboarding and troubleshooting

Your profile

Scientific background with a strong interest in IT or IT background with a strong interest in science.

Required

  • An affinity with both scientific (laboratory) and IT environments
  • Previous experience in a similar role
  • Experience in a regulated environment
  • Excellent communication skills with a customer-oriented approach for internal stakeholders
  • Highly organised and detail-oriented
  • Ability to work independently while thriving in a team setting
  • Analytical mindset and attention to detail
  • Proficient in written English

Pluses

  • Knowledge of software validation principles
  • Familiarity with quality standards
  • Proficient in spoken English

Why join Quality Assistance?

At Quality Assistance, we believe that professional fulfilment starts with the quality of human relationships. Here, everyone thrives in an environment built on mutual respect, kindness and collaboration.

Join our analytical CRO and help accelerate access to innovative medicines. Our ambition is clear: putting science at the service of health, to meet patients’ needs faster and more efficiently.

By joining us, you will benefit from a competitive salary package aligned with industry standards, including numerous extra-legal benefits (meal vouchers, hospitalisation and outpatient care insurance, group insurance, bonus scheme).

From day one, you will follow a comprehensive training programme designed to develop your skills and support your career growth. Because helping our people grow also means contributing to research.

Did you know that in 2024 we welcomed, onboarded and trained 27 new colleagues? We also promoted 30 employees internally (vertical mobility), and 5 positions were filled by internal candidates.

Employee well-being is a top priority for us. We create plenty of opportunities for you to settle into your new work environment and get to know your colleagues (after-work events, sports and leisure activities, team buildings, departmental dinners, year-end parties, BBQs, family events, and more).

You will also enjoy many free perks that make a real difference every day: fitness classes, fresh fruit available on site, and up to four complimentary car washes per year. Want to make life easier? Practical services such as lunch and bread delivery or ironing via service vouchers are also available.

Join a company that listens to your needs and values your ideas!

10 reasons to join

About Quality Assistance

Quality Assistance is a leading Belgian Contract Research Organisation (CRO) providing the pharmaceutical industry with the full range of analytical services required by EMA and FDA regulations for the development and commercialisation of innovative medicines for human use.

From the end of the screening phase through to drug registration, across non-clinical and clinical stages, Quality Assistance delivers tailored solutions:

  • We design analytical protocols;
  • We develop specific analytical methods;
  • We conduct characterisation, stability and pharmacokinetic studies, biomarker and immunogenicity testing, as well as batch control.

These analyses ensure the safety, efficacy and quality of the products entrusted to us by our clients.
With over 40 years of expertise in analytical sciences, Quality Assistance holds a unique position in the global market thanks to:

  • The centralisation of all our laboratories on a single site (Donstiennes, Belgium);
  • 270 highly qualified professionals;
  • A broad range of analytical techniques and state-of-the-art equipment.

Our working environment complies with GMP, GLP and GCLP/GCP standards.
Visit https://www.quality-assistance.com/quality-assistance/leading-analytical-cro to learn more.