Supporting the Quality Assurance manager to ensure timely handling of product complaints.
Take care of the EM CHC Europe complaint management inbox
Ensure overview of incoming complaints and monitoring of due date at the CMO and EM CHC Europe site
Assignment of incoming Complaints to the respective CMO
Assessment ad categorization of the complaint
Recurrence monitoring
Corrective & preventive actions follow up
Documentation of investigation in the system
Closure of the complaint in the system
Potential exchange with the affiliate
Contribute to the monitoring / trending of complaints.
Monthly KPI evaluation and reporting
Preparation of summary for Product Quality Reviews
Contribute in the annual CMO Risk ranking exercise
Qualification & Experienc
3 years in pharmaceutical environment, preferably in Quality, i.e. quality control/assurance, systems quality assurance and/or quality systems management experience in external quality management activities