About the job
The Shiga Quality Assurance Team is dedicated to establishing, maintaining, and continuously improving an efficient and effective quality system in collaboration with relevant departments. The team ensures that the quality systems are appropriately operated and managed, guaranteeing the quality of products and investigational drugs manufactured at the Shiga plant.
As part of the core quality assurance department for global production functions, we are tasked with exploring quality assurance directions necessary for the development and industrialization of new manufacturing technologies for products.
This position operates under the guidance of the Shiga Quality Assurance Team Manager and is fundamentally responsible for the continuous establishment, maintenance, and improvement of quality systems to provide high-quality products and services trusted by patients and their caregivers. This includes the verification of proper manufacturing management and quality control for products and investigational drugs produced at the Shiga plant.
Key responsibilities include compliance with quality manuals, management standards, and procedural documents; ensuring quality assurance based on the requirements of target markets; and assuring the quality of investigational drugs.
The outcomes and roles for this position include gathering and analyzing necessary information for reliable manufacturing management and quality control under comprehensive directives from superiors. This information will be appropriately provided and shared with relevant departments within the plant while managing progress within the team to ensure tasks are executed as planned.
In strengthening the foundation at the Shiga plant, you will collaborate with relevant departments to conduct GAP investigations on systems beyond the QA system and propose improvement plans. Furthermore, you will set appropriate procedures for your department and autonomously manage progress within the team.
Engaging your superiors and obtaining support from those around you, you will propose and execute improvement plans for maintaining and managing the quality management system for reliability assurance. You will also identify gaps against established quality guidelines and propose corrective measures, executing them as necessary.