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• Observes and follows the requirements of all applicable cGMP Directives, Regulations and guidelines
• Acts as a contact person for the market complaints received for the products under responsibility
• Registers and investigates the incoming complaints
• Coordinates complaints regarding clarification of the complaint cause, escalate in case if critical complaints
• Acts as a contact person with the supplier requesting to perform the complaint investigation
• Organizes and coordinates complaints samples management
• Evaluates supplier investigations, proposed Root Cause and CAPAs, approves and closes the records
• Tracks complaints to be completed within the deadlines
• Performs complaints trend analysis
• Storages and maintain all documents and email correspondence related to the complaint in TrackWise/database
• Creates and maintains the SOPs for Complaints management and Complaints trending
• Master Degree in Pharmacy, Chemistry, similar Natural Sciences, Engineering or other relevant education
• Preferably, at least 5 years of experience in the pharmaceutical industry in the field of manufacturing, quality control, validation, quality assurance, regulatory affairs, etc.
• Good organizational, interpersonal and communication skills
• High level of written and spoken English
• Proficiency in MS Office, SAP and Track Wise®
• Good interpersonal and communication skills as well as organizational skills
• Dynamic and challenging work environment in one of the world leading pharmaceutical company and the biggest pharmaceutical company in Bulgaria
• Competitive remuneration bound with performance
• Additional healthcare insurance
• Transportation allowance
• Flexible working hours and option to work from home as per the company policy
• Opportunity for development
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
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