Location: Barcelona, Spain
Job reference: R-209183
Date posted: 09/20/2024
AstraZeneca 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 year
Hours per day: Full time
Location: 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 management
Management 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 implemented
Management of GxP and non-GxP documentation
Product Recall/Mock Recall management
Management of self-inspection and internal Audit. Participation in self-inspections and CAPAs monitoring.
Quality Risk management
Review of Quality management
Supplier management
Participation in the collection of information for a hospital tender
Management and improvement of local and global KPIs
Quality support in the management of Market Research at a local level
Assist 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 departments
Regulatory 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.
Requirements
Qualifications:
BSc Health Sciences
MSc in Pharmaceutical Industry and related industries
High English level (spoken and written)
MS Office advanced user
Competencies: prioritization and synthesis, organization and planning, initiative and innovation, empathy, assertiveness, and ability to work as a team.
Education:
MSc in Pharmaceutical and Parapharmaceutical Industry
BSc Health Sciences
AstraZeneca is a company that promotes equal opportunities. AstraZeneca will consider all eligible persons, without discrimination based on disability, sex or sexual orientation, pregnancy or maternity/paternity period, race or origin (national or ethnic), age, religion or belief, identity of gender, marital or de facto partnership status and/or any other characteristic protected by law.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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