QC Senior Engineer SAP QM – Joblevel 9
Reporting to: Global Supervisor QC • Stability & QC master data
Objectives:
As QC Senior Engineer SAP QM you are responsible for the master data maintenance of SAP QM. You ensure, in cooperation with the ICT department for the proper engineering, proper operation and maintenance of the SAP QM and interfaces, if applicable. Be the first contact line during SAP QM projects.
In this way you help guarantee quality by following up and ensuring that all processes and actions are carried out according to the cGMP quality standards applied at Prothya Biosolutions. This is done in such a way that the pharmaceutical products of Prothya Biosolutions, its partners and its customers can be released in time and meet the European and American cGMP guidelines.
Main responsibilities:
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Manage and follow up of all related SAP QM projects
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Manage and execute investigation and root cause analysis in case of deviations (Event, CAPA, Change Control,…..)
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Responsible of all procedures and flows of SAP QM
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Be the first point of contact of SAP QM projects
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Provide training to the end-users within QC department and other business units
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Propose improvements and simplify the SAP QM processes with collaboration with customers
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Be flexible and drive for the business continuity
Profile:
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Bachelor degree in a Pharmaceutical Industry or IT, preferably SAP but not exclusively. Familiarity with European and American GMP (Good Manufacturing Practices) guidelines and SOPs (Standard Operating Procedures) is an asset;
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Experience in working with SAP QM and Microsoft Office.
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Experience in master data management (Is an added value)IT and GMP oriented
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Language skills: French or Dutch and good knowledge of English (both spoken and written)
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You are analytical and feel at home both in a lab and in a project environment
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You can set priorities and have strong organizational skills
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You are communicative and like to work together
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You are customer friendly and service oriented
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You are stress resistant and result oriented.
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Other qualities appreciated: open mindset, eager to learn, intellectual curiosity, personal investment regarding learning program.
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!
Application Process
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Interested candidates are invited to submit their CV along with a brief motivation letter. We look forward to reviewing your application.