REQ-10073496
apr 07, 2026
Spain
Resumé
EU Local Distribution Qualified Person for investigational medicinal products IMPs and auxiliary medicinal products AMPs
About the Role
Major Accountabilities:
- Batch certification / batch release of investigational medicinal products IMPs and auxiliary medicinal products AMPs in EU Local Distribution
- Collaboration with local COs (SSO, Depot, NCQ)
- Review and approval of quality-relevant Documentation to support batch release
- Ensure compliance with local and international regulations
- Continous improvement of QA system and processes
- Systematic improvement of compliance and operational level
- CAPA Management
- Support in Complaint handling
- Change Control Management
- SOP preparation and review
- self-reliant Project Management
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products
Work Experience:
- Audit & Inspection Management
- Quality Management Systems
- Quality Assurance
- GxP Experience
- Good Manufacturing Practices (cGMP)
- Quality Compliance
- Drug Development
- Research
- Technological Expertise
- Complaints Management
- Good Laboratory Practice (GLP) Analytics
- Incident Management
- Deviation Management
- Corrective and Preventive Action (CAPA) Knowledge
- Third Party Management
- Change Control Management
- SOP (Standard Operation Procedure) Management
- Patient Safety
- Pharmacovigilance
Skills:
- Pharmacist
- Qualification as a Qualified Person according to EU Legislation
Languages:
- English
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
Development
Quality
Spain
Barcelona Gran Vía
ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.
Quality
Full time
Regular
No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
