OOS / Exception Specialist

Google Chrome Microsoft Edge Apple Safari Mozilla Firefox OOS / Exception SpecialistFull-timeCompany DescriptionEurofins BioPharma Product Testing Leiden B.V., part of the globally operating Eurofins Scientific network, is a leading GMP-certified contract laboratory serving the (bio)pharmaceutical industry. Based at the Leiden Bio Science Park, we provide a comprehensive range of microbiological, viral, chemical, and physical quality control testing for pharmaceutical raw materials, intermediates, and finished products. In addition to our standard test packages, we develop and validate productspecific methods in close collaboration with our clients, and we also offer smallscale manufacturing services. We have a professional team consisting of a mix of young and experienced people with different backgrounds and experiences. Together we strengthen global healthcare and help advance the pharmaceutical product quality and patient safety worldwide. Job DescriptionAs OOS / Exception Specialist you are supporting our QC Analysts with the follow-up of deviation results of their performed assay in the QC laboratory. In this specialist role you work together with the involved Analyst, Lab Supervisor and QA to lead the investigation. You also communicate with clients regarding the Out of Specification or Exception for possible re-testing and exception reporting.As OOS / Exception Specialist, you will be responsible for:Immediate troubleshooting after detection of unexpected testing results or any other irregularities in the primary testing process.Decision making to open an Exception – or OOS record in eLIMS, in agreement with department management and QA.Client notification and follow up communication (if required) in the case of a client specific OOS or critical Exception in agreement with QC review, QA and relevant client specific Quality Agreement.Leading the investigation in cooperation with the relevant stakeholders and clients (if needed) and apply root cause analysis tools.Propose (re)testing plans and gather approvals from QA and clients (if required).Proper technical writing and finalization of exceptions within due dates and in-line with expectations from QA policy, GMP guidelines and applicable regulations.Proposing and implementing CAPAs in cooperation and agreement with the responsible department and QA.Execute (re)training of involved staff as part of the OOS – or Exception investigation where needed.QualificationsWe are looking for someone with experience in troubleshooting deviating lab results. The ideal candidate for the OOS / Exception Specialist has:Completed a BSc or MSc education in Biopharmaceutical Sciences, such as Chemistry, Biology or in a similar discipline.At least 3 year of work experience in deviation management.Working experience according to GMP (Good Manufacturing Practices) in the (bio) pharmaceutical industry.Good command of the English language orally and in writing is required. Dutch is considered a plus.Excellent communications and organizational skills to interact with clients and internal stakeholders.Flexible mindset in order to work effectively in a dynamic environment.A responsible, analytical and pro-active attitude to resolve the OOS and Exceptions in a tight timeframe.You are located in the Netherlands, or you are planning to relocate to the Netherlands and are in possession of a valid work permit.Additional InformationEurofins BioPharma Product Testing Leiden B.V.: A world of possibilities   This position is based at Eurofins BioPharma Product Testing Leiden on the Bio Science Park in Leiden. We have a close-knit team where collegiality and collaboration come first. We offer a responsible and challenging position within the team with room for your own ideas and input. Eurofins BioPharma Product Testing Leiden also offers:    A competitive salary;   Flexible working hours;   25 days of vacation with the option to purchase 7 additional days (based on...