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:
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…).
We are looking for professionals with these required skills to achieve our goals:
- University degree with scientific background (biology, chemistry, pharmacy, …), or minimum 5 years of experience in the pharmaceutical industry (preferably with QC tests related background)
- Perfectly fluent in French 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.
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