QA Specialist

Vitalograph is a leading manufacturer of medical respiratory diagnostic devices and software, used in the diagnosis of respiratory disorders, and advanced high-reliability equipment and software systems used in respiratory end-point clinical drug trials. We have designed, developed and manufactured respiratory diagnostic devices, software, and consumables for healthcare professionals, for 60 years. Headquartered in the UK, Vitalograph has operations in Ireland, Germany, and the USA. We are now recruiting for a QA Specialist to join our growing team in Buckingham. With celebrating 60 years in business, expansion plans and growth in the market, now is a fantastic time to join Vitalograph!Responsibilities:Documentation Control to include, issuing new documentation, managing change control and maintenance of tracking spreadsheets.Ensure QA tracking spreadsheets are kept up to date.SmartSolve administration of training, document control and user profiles. Maintain list of controlled documents, including biennial review dates and status.Perform study file reviews as per the study file review schedule and maintain file review trend dataReview and administration of VIRs.Assist the Clinical Trials Archivist with management of the Central Filing room.Reviewing documents against applicable regulations, QMS and other study documents, and providing feedback to the Pharma Team for key documents within studies.Assisting with problem solving issuesPerform Internal Quality Audits as required by QA SupervisorSupport successful external quality audits as required by QA Supervisor.Requirements:Computer literacy e.g. MS Word, Excel PowerPoint and Visio.Demonstrated organizational skillsWorking knowledge of ICH GCP and appropriate regulations*Experience of audits in pharma or devices arena preferable.Experience in administrative tasks in document management an advantageWhat you'll get in return:Supportive and dynamic workplaceSee a real world difference in your work by supporting world class Respiratory Clinical TrialsExcellent company pension schemeDeath in service benefit of 4 x salaryCompany paid private medical insuranceExciting progression opportunitiesLearning & Development initiatives