Quality Assurance Scientist for QA Operations

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Quality Assurance Scientist for QA Operations

Søborg

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Join a dynamic and international company where everyone is responsible for delivering right on time as one team!

The QA Operations team is looking for an experienced QA scientist to assist with quality assurance of manufacturing activities and batch release of a biological API for phase III clinical trials and Process Performance Qualification (PPQ) for commercial approval in the US and EU.

As QA Scientist you will be involved in various daily operational tasks in a dynamic and challenging environment. The team handles review and approval of quality documentation e.g. QC documentation, Batch Production Records, Master Production Records, specifications, analytical procedures, stability documentation, validation processes (manufacturing process and analytical method validations), change requests and deviations.