QA consultant - Commissioning & Qualification

Job Description

We’re supporting one of our biggest clients in Belgium in the set-up of two brand-new manufacturing facilities for the revolutionary new CAR-T cell therapy used to treat blood cancers. Our QA team of commissioning & qualification consultants is responsible for ensuring compliance of qualification activities through review and approval of system qualification and calibration/certification documents, change controls and event/deviation records.

We're currently looking for an experienced QA professional to accelerate our activities at the Ghent site.

Your role will be to

• Review and approve all qualification and system documents
• Qualify all the building systems and infrastructure
• Safeguard compliance & secure system ownership for buildings & utilities
• Keep the plant in ‘audit readiness’
• Own specific compliance aspects across the CAR-T footprint
• Be the spokesperson during regulatory & statutory audits
• Take care of compliance SME towards maintenance / projects
• Be responsible for daily operational compliance e.g. Chance Controls, Quality Investigations, …
• Approve qualification plans, protocols & reports
• Own programs and action plans to improve compliance status
• Guard the GxP processes in as a true QA professional

Your profile

• A University Master's degree in a relevant scientific subject (bioscience, chemistry, pharmacy, healthcare, ...)
• Fluent in English and Dutch
• 5 years relevant experience in a GMP environment, preferably in QA - C&Q roles
• Experience with aseptic manufacturing, HVAC, Utilities, and clean room testing is a strong asset.
• A consultancy mindset :
  • Ready to jump in a new project, quickly gain the skills and knowledge needed to support your client, and seeing any challenge as an opportunity to (im)prove yourself.
  • Socially fluent: build your professional network at both the client and Capgemini.
  • Business acumen: Analyze and evaluate the client's organization to identify their challenges and needs, so we can offer them solutions.
  • Knowledge capitalization: capture and share your knowledge and expertise with other consultants and make use of Capgemini's tools to boost yourself.

What we offer

• Within Capgemini, you will be part of a global company with endless opportunities, yet we offer a very individual and personal approach and follow-up of each consultant through small teams, led by dedicated Team Managers here in Belgium.
• Challenging and meaningful projects, attuned to your own skills and interests, at the most renowned pharmaceutical companies in the world.
• The entire knowledgebase and expertise of Capgemini to support you on your projects and develop your own skills through live trainings, e-learning platforms, knowledge sharing workshops, coaching by senior consultants, etc...
• An extensive and transparent career framework allowing you to plan and follow your own career path: whether you want to grow into a senior consultant/expert/architect or move into Team/Account/Solution/Project Management, we are here to help you achieve your maximum potential.
• A highly competitive and broad salary package, including company car with fuel/energy card.