Job Description

Main responsibilities: Complaint management of portfolio from Contract Manufacturing Organizations in line with current GMPs, and company requirements 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 Experience: 3 years in pharmaceutical environment, preferably in Quality, ie quality control/assurance, systems quality assurance and/or quality systems management experience in external quality management activities experience in management of CMOs, subcontractors / suppliers Soft skills : Ability to work in the diverse team (several locations) Communication skills Problem solving Being proactive Team work Strive for results Committed to customers Technical skills : Commit to customers Cooperate transversally Analytical and structured way of thinking, high sense of responsibility Education : Qualification in Pharmacy or Natural Sciences Good oral and written communication skills Sound knowledge of pharmaceutical regulations/GMP Languages : Good English language skills to effectively negotiate and communicate verbally and in writing

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