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QA consultant - Commissioning & Qualification

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.

About the company

World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 55,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet.

Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of over 340,000 team members in more than 50 countries. With its strong 55-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fueled by the fast evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering and platforms. The Group reported in 2021 global revenues of €18 billion.

Get the Future You Want | www.capgemini.com

Chloé Olivet | Contact Person

I'm interested
Capgemini Engineering

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