We are looking for a Quality Specialist with experience in deviation investigations and CAPA management within a GMP-regulated environment - ideally with strong knowledge of processes related to monoclonal antibodies.
This role is critical to ensuring regulatory compliance, preventing recurring issues, and strengthening the quality system through effective corrective and preventive actions. […]
Conduct thorough and well-documented investigations of deviations in the manufacturing process of monoclonal antibody-based products.
Perform root cause analyses using structured methodologies (e.g., 5-Why...