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.
Get the Future You Want | www.capgemini.com
Capgemini Engineering is the world leader in engineering and R&D services. Capgemini Engineering offers its clients a unique value proposition to meet their transformation and innovation challenges. Capgemini Engineering supports its clients, from concept through industrialization, to develop the products and services of tomorrow and has been working for more than 35 years with major players in many sectors: Automotive, Aeronautics, Space, Defense & Naval, Rail, Infrastructure & Transport, Energy, Industrial & Consumer, Life Sciences, Communications, Semiconductor & Electronics, Software & Internet, Finance & Public Sector. Capgemini Engineering has more than 50,000 employees operating in over 30 countries.
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!
- Provide support to develop process documents that are in alignment with our clients regulatory expectations and internal global policies and standards
- Ensure QA oversight
- Support change control and its implementation
- Support the development of transversal GxP Process
- Participate in handling customer complaints
- Investigate deviations and non-conformities in cross-functional teams
- Initiate and assure following up on CAPA (Corrective Action Preventive Action)
- Review batch records in accordance with release requirements
- Review validation documentation (Production, Quality Control…)
- Help write and assess APR (Annual Product Review) and QPR (Quality Performance Review)
- Ensure compliance with standards (FDA, EMA, ICH, ISO…)
Based on your profile and expertise your job content will be specified in the following directions:
- QA oversight in Validation activities (IQOQ / PQ / PV…)
- Drive and execute continuous improvement project or remediation plan related to Sterility Assurance
- Writing, reviewing and approving Computer System Validation specific plans, reports, protocol’s, SOP’s etc.
- Overseeing as a Program Manager the coordination and administration of all aspects of ongoing program activities.
- You hold Master degree in (bio) engineering or related scientific domain,
- You speak French or Dutch and you are fluent in English,
- You have a first experience in Quality Assurance in a GxP environment
- You have knowledge of Pharmaceutical Industry, Medical Devices, Biotechnology or Food technology