Quality Assurance Specialist Release

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.comJob FunctionQualityJob Sub FunctionQuality AssuranceJob CategoryProfessionalAll Job Posting Locations:Uppsala, Uppsala County, SwedenJob DescriptionJ&J MedTech is recruiting for a QA Specialist Release reporting to the Manager QA/QS and to be based in Uppsala (Sweden). The contract is a 1-year fixed term one for maternity cover.In Uppsala, we manufacture Healon, a market-leading product used to stabilize the eye in connection with eye surgery. Upon its launch in 1980, Healon paved the way for safe and quick eye surgery, whereby a patient’s cataracts can be replaced with new lenses in just a few minutes.Job Position SummaryRelease final packed product to market (Including material needed)Review and approve documentation for disposition decisions regarding media, raw materials, incoming materials, components, pre-treated components, substance and products according to current qualification programsDevelop and improve quality management processes and ensure that quality management processes within AMO Uppsala meet the requirements of the Division / CompanyQuality assurance deviations and CAPAsConduct trainings within GMP / QMSDuties & ResponsibilitiesApprove and verify deviations, actions and CAPA investigationsReview and approve standard operation procedures/work instructions (in e.g. validation, manufacturing, trials)Quality assurance of raw materials, packaging components and productsMake dispositional decisions for media, raw materials, pre-treated components, incoming materials, components, substance and products according to current qualificationsContinuous improvement of the quality management systemCreate/ update and approve specifications/inspection plansExperience & EducationMinimum three-year academic university education with a pharmaceutical, scientific or technical orientation or equivalentKnowledge of GMP/ISO regulations (EU GMP, 21 CFR Part 820, ISO 13485, ISO 14001)Good oral and written proficiency in English and Swedish (local language)1-3 years of experience working in GMP/ISO controlled operations in the pharmaceutical industry and/or Medical Device.Good in taking initiativesFluent knowledge of English and Swedish languages