This position is responsible for executing validation activities at the Narita site, qualifying equipment, critical systems/utilities, computerized systems, and cleaning/sterilization processes to ensure continuous cGMP compliance
Job Summary
This position is responsible for executing validation activities at the Narita site, qualifying equipment, critical systems/utilities, computerized systems, and cleaning/sterilization processes to ensure continuous cGMP compliance.
The role involves managing validation personnel and projects within quality, time, and budget constraints, coordinating appropriately with Engineering, Manufacturing, Regulatory Affairs, Quality Assurance, and Quality Control departments.
Takeda offers a comprehensive compensation and benefits package including allowances, annual salary increases, twice-yearly bonuses, and a variety of paid leaves and flexible work styles.
Matching Summary
This position is responsible for executing validation activities at the Narita site, qualifying equipment, critical systems/utilities, computerized systems, and cleaning/sterilization processes to ensure continuous cGMP compliance.
Skills & Requirements
Must-have
Native level Japanese proficiency
cGMP compliance
Validation strategy development
Cross-functional team coordination
Regulatory authority inspection support
Nice-to-have
Leadership and project management skills
Problem-solving and decision-making
Interpersonal and negotiation skills
Adaptability to controlled environments
Key Requirements
Bachelor's degree in Engineering or Science preferred
Experience in manufacturing processes, control systems, cleaning processes, process equipment, facilities, temperature-controlled units, and critical support systems
Experience interacting with FDA and other regulatory authorities