Quality Assurance Expert

Coordinate all Compliance related aspects in order to ensure that products produced in the site and materials used and /or product meet the appropriate Quality Standards in Line with Company, cGMP requirements as well registration files: deviation management and related timely and effective investigation management including a follow up on CAPA plans; planning, organization and execution of internal and external audit including follow up on CAPA plans; risk Management and Root Cause Analysis; supporting all the informatic system activities related to Quality aspects (i. e.
Validation activities); encourage a continuous improvement culture; provide expertise in the review of validation protocols, reports and investigations carried out during processing problems and deviations.   Who you are:  Scientific degree (e. g. , Pharmacy, Biology or Chemistry) Languages: Fluent in  Italian and English Experiences: 1- 3 years’ experience in the pharmaceutical industry with a particular knowledge in  Quality, Quality Risk Management; Deviations, Environmental Monitoring Deviations; Aseptic technique; Quality System in general;   Investigation practices like Root Cause Analysis, CAPA management, Validation skills Job related skills & Knowledge: Good inter-personnel relationship inside the plant and prompt reaction to external problems; good knowledge of EU Eudralex rules and US CFR 21 210, 211 Profound customer-orientation with an eye for the company’s own interests Flexibility and keen pursuit of innovation throughout all processes in the continuous search of sustainable new ideas Strong desire to develop and grow by way of taking responsibility and engaging in additional tasks and operations