Job description
· Developing and ensuring compliance with quality plans and programs
- Coordinating regulatory inspections under the manufacturing and wholesale distribution licenses
- Implementing regulatory compliance in cooperation with the Regulatory Affairs Manager
- Monitoring of Group quality standards and their implementation in the local QMS
- Recording and initial assessment of reported cases of drug risks or suspected cases where pharmaceutical-technical defects are involved
- Collaboration and point of contact for Customer Service/KAMs/Medical Information and other departments regarding complaints.