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About The Position
Join our newly formed team within the Quality division at Alvotech, a leading biosimilar pharmaceutical company. As a Specialist in Engineering & CSV Compliance, you will collaborate with various departments to oversee qualification and validation activities for facilities, utilities, and equipment. You will serve as a Quality representative and subject matter expert, ensuring compliance with EU and US legislation for parenteral manufacturing. Your role will involve supporting QA oversight, reviewing and approving qualification documents, change controls, deviations, and CAPAs, and contributing to investigations and corrective actions. We seek a candidate with a bachelor's degree in a relevant area, at least 3 years of experience in the pharmaceutical or medical device industry, and a strong understanding of GAMP 5 guidelines.
