Compliance Engineer; Site Conformance | Life Sciences

Position: Compliance Engineer (Site Conformance) | Life Sciences
Location: Town of Belgium

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Diegem# Compliance Engineer (Site Conformance) | Life Sciences##

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.
*** 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, Women@Capgemini or Cap Ability are 3 examples of employee led networks dedicated to advance diversity, equity and inclusion within workplace and society.

Experience level

Experienced Professionals Location Diegem
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