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AI Summary
The role involves developing quality plans and ensuring compliance with regulatory standards and Group quality systems. It also focuses on assessing drug risks, handling pharmaceutical defects, and coordinating with various departments regarding complaints.
· 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.
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