QA Engineer
il y a 3 semaines
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? 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.
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 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 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 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.
You have a Master's degree (preferably in Chemistry, Industrial Pharmacy, Biotechnology, Biomedical sciences etc.) 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; 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. Knowledge of quality systems.
Fluency in English, with knowledge of Dutch and/or French as an asset.
knowledge of SAP/MasterControl is an asset.
Experience in the pharmaceutical, medical device or biotech sector.
We also offer an attractive holiday system exceeding the legal holidays and 1 day homeworking after a successful onboarding (after 3 months).
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