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Compliance Engineer (Site Conformance)
role at
Capgemini Engineering
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Join to apply for the
Compliance Engineer (Site Conformance)
role at
Capgemini Engineering
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At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.
Job Description
We are seeking a talented Site Conformance Engineer to ensure as quality representative compliance to regulatory dossier of activities related to Manufacturing or Quality Control Departments. You will join the QA Release team and support during the requirements of Good Manufacturing practices (cGMP).
Key Responsibilities
Review and/or approval of variations/submissions/RTQ/Commitment + provide technical support to Regulatory Affairs (RA) departments
You support Manufacturing or Quality Control Departments for CMC processes.
On quality oversight of source documents and providing operational documents to support Regulatory Affairs in authoring post approval changes’ variations.
Review, on behalf of Operations, submitted documents to Health Authorities in the frame of Regulatory Submission Process.
Support Questions & Answers and Commitments process within Manufacturing or Quality Control Department.
Support QA and Manufacturing in the prioritization of the CMC subjects in their area.
You provide technical support to RA in communication to and from Health Authorities in the frame of post approval changes management.
You provide CMC and regulatory conformance expertise to support release of products in compliance with marketing authorization through deviation assessment, visibility to registered details, post approval changes guidance.
Job Description - Grade Specific
Your Profile
Master’s degree and minimum of 2 years of experience in the pharmaceutical industry.
Having knowledge of legislation related to license acquiring and post approval changes management.
Having knowledge of the CMC dossier and GMP.
Technical understanding of product manufacturing processes and/or testing of vaccines.
Strong quality and results oriented mindset
Good communication skills
Fluent in English and professional level of French.
What You Will Love About Working Here
At Capgemini Belgium we offer flexibility in more than one way: next to our hybrid way of working, where we offer you can work 70% from home, we also offer our flex abroad program. With this program you can work up to 45 days abroad, this to maintain a good work-life balance.
Our mission is your career path. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities.
OUTfront, or CapAbility are 3 examples of employee led networks dedicated to advance diversity, equity and inclusion within workplace and society.
Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. xphnsxz It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.
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