Plan and implement the MSA (Measurement System Analysis) system, assisting the FAB in performing calibration and capability assessment of measuring instruments to ensure the reliability of measurement values and thus ensure product quality.
In accordance with regulatory requirements related to MAH (Marketing Authorization Holder), BLA (Biologics License Application), and other applicable regulations, coordinates, compiles, reviews, and ensures the completeness, accuracy, and timely submission of all project-related quality and regulatory documentation packages.