Compliance with local and international regulations
Capa management
The role involves batch certification and release of investigational and auxiliary medicinal products within EU local distribution
Job Summary
The role involves batch certification and release of investigational and auxiliary medicinal products within EU local distribution.
The Quality Manager collaborates with local contract organizations and ensures compliance with local and international regulations while driving continuous improvement of QA systems and processes.
Responsibilities include CAPA management, complaint handling, change control management, SOP preparation and review, project management, and reporting of technical complaints and adverse events related to Novartis products.
Matching Summary
The role involves batch certification and release of investigational and auxiliary medicinal products within EU local distribution.
Skills & Requirements
Must-have
Batch certification and release
Compliance with local and international regulations
CAPA Management
Change Control Management
Quality Management Systems
Complaint handling support
Nice-to-have
Business Partnering
Collaboration and Communication Skills
Data Integrity
Digital saviness
Leadership
Operational Excellence
Problem Solving Skills
Key Requirements
Qualified Person according to EU Legislation
Pharmacist Qualification
Experience in Audit & Inspection Management
Experience with Good Manufacturing Practices (cGMP)