Job Description SummaryThe QA Specialist manages all aspects and projects within the Quality Assurance department. They guarantee and support GxP conformities and Novartis Quality System.Job DescriptionMajor accountabilities:Support technological and organizational interventions aimed at the improvement of manufacturing processes in terms of quality, productivity and costs and the optimization of the resources relating to the site.Ensure that the company manufacturing objectives and policies are consistent with GMPs.Support the development and implementation of projects related to new or existing products.Approve/verify the documentation (batch record, specifications, sampling and control methods, procedures of the Quality Management System, protocols).Ensure the update of the lists of documents related to the Quality Management System based on the indications of the reference SOPs.Draft Annual Product Quality Review and collaborate in drafting of Site Master File.Manage the product complaints, CAPAs and change controls.Review and approve the investigations in case of analytical results out of specification (OOS), out of trend (OOT), out of expectation (OOE) or System Suitability Test failures.Support the preparation and execution of internal audits and Health Authorities inspections and the execution of Self Inspections.Manage the Supplier Qualification.Essential requirements:Scientific Degree.Previous experience within the Quality Assurance department of a pharmaceutical/biotech company.Clear and effective communication skills.Fluent in Italian and English.Willing to relocate to Saluggia with the flexibility of working from home 1x/week.Skills DesiredSkills DesiredContinued LearningDealing With AmbiguityGood Documentation PracticeGuidelineKnowledge Of CapAQa (Quality Assurance)Quality ManagementRegulationSelf-AwarenessTechnological ExpertiseSummaryLocation: SaluggiaType: Full time
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