Quality Assurance EM/Sterility Consultant

About Capgemini

Capgemini is a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided everyday by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of 270,000 team members in nearly 50 countries. With its strong 50 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 2020 global revenues of €16 billion.
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Our offer

At Capgemini Engineering we value excellence, care, responsibility, dynamism and innovation. We offer a job with variation that leaves plenty of room for initiative and development. In fact, we are not just offering you a job, we’re inviting you to be part of our community where we will provide you trainings, tools & grounds for professional and personal growth. Each career experience is assorted by an attractive salary package.

If you are a team player, if you recognize yourself in this profile and are not afraid of taking on challenges… Apply today!

Your role

  • You will manage and execute continuous improvement projects or remediations plans to sterility assurance (incl. change control management, SOP’s review)
  • You will manage relationship with aseptic operations
  • You will identify potential quality and compliance risks and help to manage these risks through the existing quality systems
  • You will performs gap analysis, system effectiveness reviews and other management reviews
  • You will guarantee the maintenance of the cGMPs in the area of responsibility (SOP, documentation, audits, training, method validation)
  • You will ensure and support the implementation of adequate training and practices related to sterility assurance, including shop floor mentoring
  • You will contribute to intern QA meetings to share knowledge and practices and to review sterility assurance issues as to foster continuous improvement and manage risks

Your profile

  • Master degree in (Bio-)engineering, Chemistry, Pharmacy or related domains,
  • Fluent in French and good level of English,
  • A previous experience in the (bio)pharmaceuticals, medical devices or biotechnology sector
  • A relevant experience of minimum 2 years in sterility assurance
  • Knowledge of GxP
  • Hands-on approach, able to work on the shop floor, coaching and mentoring style, strong communication skills

Ref:

84741

Posted on:

June 2, 2021

Experience level:

Mid level

Contract type:

Full-time