description du poste

We are SIMABSSIMABS is a biotechnology venture that provides cost effective therapeutic monoclonal antibodies to biopharmaceutical companies. We are hiring a QA Engineer who has a startup vibe to join our small team. Be part of our mission and set the new standard in biopharmaceutical manufacturing technology. Our values are KISS: Keep It Simple Smart, Innovate the process and last but not least, Enjoy the flow.Job contentAs our QA Engineer, you will combine project QA tasks, routine QA tasks, as well as maintenance of the Quality Management System (QMS) within the company.Responsibilities:Project QASupport implementation of new products at our GMP siteDiscuss and review tech transfer data packages and implementation documentsWrite and review project specific validation protocols reportsRoutine QAIssue master batch records and conduct batch record reviewSupport and review of Environmental monitoring activitiesRelease incoming materials and write material specificationsAssist in supplier qualification and requalificationEnsure QA oversight on Good Documentation Practices and Good Manufacturing PracticesMaintain the (electronic) Quality Management SystemReview follow-up of events, planned deviations, supplier complaints, OOS, CAPA, and change requestsWrite and review SOPs, work instructions and formsArchive records and filesPrepare management review documentationYou work closely together with the head of qualityYou engage in a broad range of activities in order to grow simAbs into a strong and reliable partner for future clients.Education:Master Degree in Biochemistry, Chemistry, Pharmaceutical Lab Technology or equivalent through relevant experience. Ideally you already have +/- 3 to 5 years of working experience in a GMP environment.Competences:Technical skills:· Skilled in GMP and Good Documentation PracticesSoft skills:· Quality minded· High degree of accuracy, well organized and result oriented team player· Fast assembly of new information· Swift learning on the job· Strong and honest communicator· Flexible both in content as in time (occasional working during the weekend, early morning, evening or night)· Enjoying the start-up flow of our organization #J-18808-Ljbffr