Function: Engineer Product Support – Stability
Report to a Global Supervisor of the Quality Control Support Global department.
Objectives:
In your role as Engineer, you will focus on Stability, and you will participate in (improvement) projects. You can be a support in the other topics managed by the team.
You will join a multidisciplinary team that aims to manage and maintain at Prothya Biosolutions Belgium:
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Stability studies of manufactured (intermediate) products
Main responsibilities and results:
In your daily activity, you report to the Global Supervisor of the Stability and QC Master Data team which is part of the Quality Control Support Global department.
Your main responsibility will be:
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Stability Management
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Planning ;
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Protocol creation;
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QC testing follow up ;
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Raw data follow up and report creation;
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SOP management.
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Alignment with Prothya Biosolutions Netherlands for the stability topic.
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Make improvements related to Stability
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Opening records in the Quality Management System (eg. Master Control), make investigations and planning for a good follow up.
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Communicate the result and follow up of your activities with other departments and different hierarchical levels.
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Participate to other team (improvement) projects, therefore your critical eye and constructive feedback will be an asset.
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As SME for Stability, you will support other departments in various projects.
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Participate as SME for Stability during client or regulatory audits.
Profile:
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Education level: Master (Engineering, Biotechnology, Biochemistry, …) with at least 3 years of experience in a quality-driven sector (pharmacy, food, chemistry …).
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Strong understanding of stability study design, protocols, and regulatory requirements (ICH and EudraLex GMP guidelines)
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Ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulatory requirements throughout the stability testing process.
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You can set priorities and you are flexible and organizationally strong.
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You are communicative and enjoy working in a team.
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You are analytical, result-oriented, and problem-solving.
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You are customer and service oriented.
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You have a good knowledge of English and Dutch and / or French (both spoken and written).
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You have knowledge of the MS Office package and other software packages.
Our Company
Prothya Biosolutions makes life-saving plasma medicines and is proud of that! Every day, Prothya colleagues take the extra mile to improve the health of millions of patients worldwide. Are you looking for a position at a flexible and fast-growing company with an exciting history? At Prothya you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn!
We offer
Prothya Biosolutions Belgium is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training.
In return for your performance, you shall receive a competitive salary, group and health insurance, meal vouchers, and eco-cheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible compensation system through which employees can create a budget from their current salary components. Thanks to this plan, they can enjoy, on a voluntary basis and according to their personal choice, a series of benefits that Prothya Biosolutions Belgium offers once a year.
We also offer an attractive holiday system exceeding the legal holidays and homeworking after a successful onboarding (after 3 months).
Furthermore, we value mutual respect and diversity is our strength.
At Prothya, you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn!
Are you moving along? Then !
