Work Schedule Standard (Mon-Fri)Environmental Conditions Laboratory Setting, OfficeJob DescriptionQuality Leader Small ScaleManufacturing AllergyThis position is based on our site in Uppsala, where Thermo Fisher develops, manufactures, and markets complete blood test systems to support the clinical diagnosis and monitoring of allergy, asthma, and autoimmune diseases. With 1,900 employees worldwide working with these products, and 1,000 in Sweden, we are the global leader in in-vitro allergy testing and the European leader in autoimmunity diagnostics.Manufacturing Allergy in Uppsala is looking for a Quality Leader to Solid Phase Small Scale. In this role you ensure that production is compliant according to the quality management system. You collaborate with production and other supporting quality teams to ensure good progress in quality management.The job:The main responsibility for the Quality Leader is to coach production staff and managers within quality matters, as well as collaboration with other supporting quality teams to secure compliant production processes. In addition to this you will have an important role in the production of ImmunoCAP tests by learning different parts of production to be able to step in and produce, e.g. if there is a period with high demand.Compile and implement periodic review to ensure compliant productionBe spokesperson for the department for internal and external auditsCoach and support production teams within Non Conformity-handlingMake sure Root Cause Analysis is performed correctlyInvestigate CAPA-issues and complaintsSupport production (coupling and extraction) if neededKnowledge, Skills, AbilitiesWe are looking for a Quality Leader with high commitment and integrity, structured way of working and analytic mind set. You have experience from working in Life Science production and knowledge of Good Manufacturing Practice and ISO13485 and IVDR. It is advantageous to have a bachelors' degree in engineering/biology (or equivalent experience).It is also important that you can both speak and write fluently in English and Swedish.Apply now!Please apply as soon as possible, the position will be filled as soon as suitable candidate is found.
