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.