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
Manage and follow up of all related SAP QM projects
Manage and execute investigation and root cause analysis in case of deviations (Event, CAPA, Change Control,…)
Responsible of all procedures and flows of SAP QM
Be the first point of contact of SAP QM projects
Provide training to the end-users within QC department and other business units
Propose improvements and simplify the SAP QM processes with collaboration with customers
Be flexible and drive for the business continuity
Profile
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;
Experience in working with SAP QM and Microsoft Office.
Experience in master data management (Is an added value) IT and GMP oriented
Language skills: French or Dutch and good knowledge of English (both spoken and written)
You are analytical and feel at home both in a lab and in a project environment
You can set priorities and have strong organizational skills
You are communicative and like to work together
You are customer friendly and service oriented
You are stress resistant and result oriented.
Other qualities appreciated: open mindset, eager to learn, intellectual curiosity, personal investment regarding learning program.
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).
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