Engineer QA Operational

About the 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 About the Role As Quality Engineer, you are responsible for guaranteeing quality by following up and ensuring that all operations at all levels are done according to the applied GMP quality systems at Prothya Biosolutions BE. In this way, you help ensure that the quality of the pharmaceutical products from Prothya Biosolutions BE fulfils the European and American GMP guidelines. Responsibilities You are responsible for guaranteeing quality by following up and ensuring that processes and activities are carried out according to the applicable cGMP quality standards: You perform review of batch records and prepare the documentation for the release department. You assess events/deviations, OOS/OOL and complaints (to vendor). You monitor written documents such as procedures, protocols and reports concerning quality systems from other departments. You take care of the correction and authorization of those procedures, protocols and reports. You perform GxP-checks on the shopfloor in different departments and support people to improve. You participate in different projects related to risk analyses, qualification and validation: You are responsible for performing risk analyses and determining corrective and preventive measures (CAPAs). You monitor changes via Change control. You participate in or supervise quality-related projects. You are responsible for informing, making aware and training Prothya Biosolutions BE employees: You contribute to guaranteeing the quality level and you work on continuous (quality) improvement. You are responsible for informing colleagues about quality, pharmaceutical legislation and rules. You are responsible for encouraging employees to respect the pharmaceutical rules. You actively follow the commitments made to our internal stakeholders regarding batch record review and quality system records and report them to the supervisor. Qualifications You have a Master's degree (preferably in Chemistry, Industrial Pharmacy, Biotechnology, Biomedical sciences etc.) or equivalent through experience; You have at least 2 years of experience in a similar position in the pharmaceutical, medical device or biotech sector; Knowledge of quality systems is a requirement; experience with European and American GMP (Good Manufacturing Practices) guidelines and SOPs (Standard Operating Procedures) is an asset. You work efficiently with MS Office package; knowledge of SAP/ MasterControl is an asset. You can communicate fluently in English (both spoken and written), and you have a good knowledge of Dutch and/or French. A notion of both is an extra asset. You are analytical and good at solving problems. You are result-oriented and decisive. You are pragmatic. You are customer-oriented, persuasive, communicative, and cooperative. You are stress resistant. Required Skills Knowledge of quality systems. Experience with European and American GMP guidelines and SOPs. Fluency in English, with knowledge of Dutch and/or French as an asset. Proficiency in MS Office; knowledge of SAP/MasterControl is an asset. Preferred Skills Experience in the pharmaceutical, medical device or biotech sector. Analytical and problem-solving skills. Result-oriented and decisive approach. Customer-oriented and cooperative attitude. Our offer 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 1 day 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 apply now