Responsibilities
• 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.
