.About the Neuraxpharm GroupNeuraxpharm is the leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders.It has a unique understanding of the CNS market built over 35 years.Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline, partnerships and acquisitions.The company has more than 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, and globally via partners in more than 60 countries.Neuraxpharm is backed by funds advised by Permira.Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratorios Lesvi) in Spain.Neuraxpharm is searching for a vacancy based in Sant Joan Despí:QA SpecialistThe Quality Assurance Specialist is focused on providing confidence that quality requirements are fulfilled. The mission is to provide an effective and efficient quality assurance system that ensures compliance with Good Manufacturing Practice as a part of Quality Management, ensuring that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation and product specification.Major Accountabilities:Write, review or approve technical documents: SOP, master and batch manufacturing records, analytical methods, material lists, specifications, stability studies, filed dossiers, utilities monitoring, environmental conditions, etc.Write, execute or review qualifications (equipment, utilities and facilities) and validations (process, cleaning, IT and utilities).Prepare and execute GMP trainings.Compliance (internal procedures vs filed documentation).Write and monitor CAPAs, deviations and change controls.Write and review Product Quality Review reports.Plan, review and approve calibration activities.Execute internal and external audits. Attend audits from Health Authorities and customers.Attend to requests related to marketed products regarding quality, administration and storage.Participate in assigned projects.As Quality Shopfloor specialist, manage CAPA, deviation and change control.Manage the plant and laboratory calibration plan.Production shopfloor QA area.Write and review Product Quality Review reports for assigned products.Review packaging effervescent area qualifications.Support and answer customer queries about the assigned products.Manage the assigned I+D projects.Requirements:2-5 years of experience in a Quality Assurance Department.Bachelor's or Master's degree (completed or in process) in Pharmacy, Life Sciences, Engineering or Chemistry.Proficient level of English and Spanish.Specific Knowledge: GMP, Quality Management System, IT: Office, SAP, LIMS.QP experience is valuable
