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Quality Control / TT Analytical Method Transfer
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Industry

Engineering Services

Category

Other

Experience

Mid level

Applications are considered on a rolling basis

Location: Multiple locations

Workspace type: On-site

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Contact Person
Chloé OLIVET

Job Description

About the Job

Joining Capgemini Engineering means becoming part of a global organization that drives innovation and growth. With over 55 years of experience, a presence in 30 countries, and more than 55 000 employees, we offer an environment where you can elevate your career to new heights.

And that’s not all! As a Quality Control / TT Analytical Method Transfer consultant, you will play a pivotal role as a QC coordinator and as SPOC for all the QC tests. Together with your team, you will work on exciting projects in the pharmaceutical sector.

Your Responsibilities

In this role, you will be responsible for:

  1. Coordinate the Quality Control (QC) tests transfer activities between different Manufacturing sites and between a site to other external collaborators (CMO) up to the routine commercial operations
  2. Be the SPOC (Single Point Of Contact) for all the QC tests transfer aspects in collaboration with the Manager of the project
    • Ensure a close follow-up of the QC activities by providing adequate technical support during the QC tests transfer process, in collaboration with QC commercial department
    • Supports Project Teams in setting and continuously reviewing QC tests transfer progress, according to the global project plans, milestones and timelines. Escalate issues if appropriate
    • Participate in establishing the Risk assessment specific for the QC tests activities, for all the projects involved
    • Organize the trainings of the external collaborators, required for the QC test methods transfer, in donor site premises, in collaboration with the QC commercial department
    • Request and coordinate the reagents shipments between sites to support the QC tests transfers, and provide support to lean the shipments process, in collaboration with QC and logistics departments
    • Build the specific Tech Transfer documentation,- document these analytical transfers according to the predefined rules/SOP
    • Participate to the writing of Test Transfer Plan at the beginning of a project, or when required
    • Participate to the writing of the test transfer method protocols. Use statistical tools and QC tests validation protocols/reports to define the tests transfer criteria, in collaboration with QC statisticians, QC and QA colleagues
    • Analyze the QC results obtained locally and write the final report document
    • Participate in change initiatives involving Tech Transfer team (Process harmonization, QC samples management process improvement, documentation, ways of working, or other specific TT working groups, etc…)

Your Profile

At Capgemini Engineering, we’re looking for someone with:

  • University degree with scientific background (biology, chemistry, pharmacy, …), or minimum 5 years of experience in the pharmaceutical industry (preferably with QC tests related background)
  • Fluent in French or Dutch and English (spoken and written)
  • Good communication and negotiation skills and diplomacy approach when dealing with colleagues within or outside the organization (in Belgium and abroad)
  • Good technical writing and teaching skills, good computer skills
  • Scientific background of the “in vitro” “in vivo” QC analytical methods is a plus

What We Offer

At Capgemini Engineering, we offer more than just a job:

  • A full-time position with attractive secondary benefits
  • A competitive salary package, including a company car, laptop, meal vouchers, bonus system, and more
  • Training and development: Access to courses and certifications to enhance your skills
  • Flexibility: A hybrid work model that supports work-life balance
  • Regular company outings and events to celebrate success together

Recruitment Process

Our recruitment process includes the following steps:

  • A first screening via phone
  • An initial interview with a Talent Acquisition Professional
  • A discussion with one of our People Managers to ensure the right fit
  • A meeting with our Technical Colleagues to assess your skills and experience

Ready for the next step? Apply now and explore how your future could look at Capgemini Engineering!

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

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