CSV Quality Assurance Specialist

UCB

  • Braine-l'Alleud, Brabant Wallon
  • CDI
  • Temps-plein
  • Il y a 1 mois
Make your mark for patientsWe are looking for a CSV Quality Assurance Specialist who is detail-oriented, collaborative, and resilient to join our Bio drug substance Quality – BE team, based at our UCB campus located in Braine-l'Alleud, Wallonia, Belgium.About the roleYou’re going to play a key role in ensuring the quality and compliance of computerized systems in our new biological drug substance facility. You will help shape a reliable and efficient validation environment that supports our mission to deliver high-quality medicines.Who you will work withYou will be part of the Quality Support Team, reporting to the Quality Validation Manager. You’ll collaborate closely with Bio Process Engineering, Validation, IT & Automation, and CQV QA specialists to ensure alignment and excellence in validation practices.What you will do
  • You will support projects as a Quality SME for computerized system validation.
  • You will be responsible for reviewing and approving validation documentation in line with GMP standards.
  • You will manage deviations, CAPAs, and change controls related to CSV scope.
  • You will guide stakeholders on GMP-compliant validation processes.
  • You will contribute and participate in audits, inspections, and continuous improvement initiatives.
For this role, we are looking for the following education, experience, and skills
  • You hold a Bachelor’s or Master’s degree in a relevant scientific or technical field.
  • You have at least 5 years of experience in the pharmaceutical industry.
  • You bring proven expertise in computerized system validation (CSV).
  • You are fluent in both French and English.
  • You are comfortable with tools like MS Office and Veeva Vault.
  • You demonstrate agility, stress resilience, and a collaborative mindset
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

UCB