Senior QA Consultant - Life Sciences

Job Description

The Senior QA consultant holds a vital and challenging role in a life science company: ensuring the quality and safety of products going to patients through building a Quality Management System. Finding a way to balance quality with efficiency, keeping up with the ever-changing world of new products, techniques and requirements, and intensely collaborating with various other departments and stakeholders, ...

We support our clients with our profound knowledge and expertise in all quality subjects. Whether they are building a new production plant, developing new analytical methods, implementing a new quality regulation, or simply trying to solve issues and close gaps, we are there to ensure their success.

Are you up for this challenge?

Depending on your project, you will:

• Assist the customer to formulate quality standards and regulations for employees and for the products
• Review requirements as set in legislations, standards and norms to ensure compliance of the Quality Management System (QMS)
• Train and manage the QA department team
• Keep the oversight on activities conducted in the QA Department e.g. management of non-conformities, CAPAs, suppliers, Quality System, Change Control,....
• Report to management non-conformities and deviations , discovered within a production plant, a laboratory, a warehouse & distribution center, that fail to meet the quality standards and lead root cause analysis and CAPA efforts to resolve/ prevent those issues
• Conduct regular Quality Management reviews to assess the progress and continual improvement of the QMS and discuss with senior management
• Review existing procedures and work instructions and develop strategies to improve processes
• Establish requirements to qualify, approve, monitor and periodically re-evaluate external suppliers
• Represent the QA department during supplier and regulatory authority audits and inspections
• Monitor quality metrics and KPIs to determine the most strategic way forward
• And much more...

Your profile

• A University Master's degree in a relevant scientific subject (bioscience, chemistry, pharmacy, healthcare, ...)
• A high professional level of Dutch, and fluent in English.
• Extensive knowledge and experience of QA within a GMP environment (≥ 8 years of experience)
• High level of autonomy and proactivity: Able to find and propose solutions and improvements rather than problems.
• Mobility towards at least one of our major clients located in Puurs, Beerse, Leuven, Wavre, Charleroi...

• A Senior 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, identify their challenges and needs, develop solutions and promote Capgemini’s offers
  • Knowledge capitalization: capture and share your knowledge and expertise within Capgemini., Guide and coach junior consultants and be their role model.
  • Work together with internal Capgemini functions (Team/sales/solution/project managers) and proactively support or launch innovation and improvement initiatives for our company.

Our 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.