Regulatory and Quality Affairs Spain

hace 3 semanas

Barcelona, España Recruiting Erasmus A tiempo completo

**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**

**Training through practical experience**:
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 Preventine 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**:

- 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.

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