.Location: Barcelona, SpainJob reference: R-209183Date posted: 09/20/2024AstraZeneca is an innovation-driven global biopharmaceutical company focused on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, renal and metabolic, respiratory and immunological, oncological and rare diseases.In line with our firm commitment to training and developing exceptional talent, this person will join our Regulatory and Quality Affairs Iberia area to learn and grow through active collaboration with our team.Conditions:Duration: 1 yearHours per day: Full timeLocation: Barcelona (Spain)Focus area:Training through practical experience:The functions do not involve responsibility in themselves, and the person will carry them out for their learning and adaptation to the position.Supporting various quality and regulatory activities, especially related with reviewing trainings, procedures and local documentation from Spain & Portugal.Quality collaboration:Support in the Quality System maintenance which includes:Deviation managementManagement of Corrective and Preventive Actions (CAPAs)Management of Complaints and Technical Questions. Reconciliation with Patient Safety (PS)Management of Change Control: monitoring the activities to be implementedManagement of GxP and non-GxP documentationProduct Recall/Mock Recall managementManagement of self-inspection and internal Audit. Participation in self-inspections and CAPAs monitoring.Quality Risk managementReview of Quality managementSupplier managementParticipation in the collection of information for a hospital tenderManagement and improvement of local and global KPIsQuality support in the management of Market Research at a local levelAssist in the preparation of documentation: creation of dashboards/reports, etc.Collaborate with the assignment of the initial and continuous training systems for all personnel involved in GxP activities.Collaborate with the supervision of the qualification and approval of GDP suppliers and clients.Support in the approval and maintenance of the quality agreed with suppliers related to distribution and/or transportation of medicines.Participation in different meetings with local and global GxP departmentsRegulatory collaboration:Support for the distribution of Spain & Portugal safety information materials and related tasks.Support in reviewing product information.Support in the review of promotional/non-promotional materials and sponsorships, and when appropriate their presentation to the Has.Collaborate with AW request management.Support to the notifications to AEMPS.Support to the MSE platform management.RequirementsQualifications:BSc Health SciencesMSc in Pharmaceutical Industry and related industriesHigh English level (spoken and written)MS Office advanced userCompetencies: prioritization and synthesis, organization and planning, initiative and innovation, empathy, assertiveness, and ability to work as a team
