Quality Assurance Staff

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Quality Assurance Staff

Tokyo, Japan

PURPOSE:

Responsible for ensuring a new or existing product meets the established standards of quality for Japan business unit.

MAIN RESPONSIBILITIES AND DEGREE OF INFLUENCE:

1. Risk assessments during development of new products, changes to existing products, promotional products, etc., and project meetings with development teams.
2. Management of quality improvement projects for existing products.
3. Arrangements for quality standards with overseas manufacturing plants and quality specifications with domestic contract factories.
4. Checking and approval of documents required for manufacturing, such as product standards, specifications and procedures, and progress management of records.
5. Production attendance and quality inspection of first production items.
6. Analysis of post-market quality trends for new and modified products.

EDUCATION: Bachelors degree or above

EXPERIENCE: 

• Required: Experience in a manufacturing-related role in the healthcare, hygiene or pharmaceutical industry. (Min 3 years)
• Preferred: Experience in quality/quality systems related work, Experience in chemistry, pharmacy or engineering related areas, Knowledge of Japanese legal regulations and industry standards such as GMP/GQP/GDP. 

KNOWLEDGE/COMPETENCES: 

• Language skills: English (Business level - required), Japanese (Native level - required)
• Analytical skills: ability to define problems, collect details data, analyze and interpret results and recommend changes and improvements. Basic knowledge on QC Tools and Root Cause Analysis techniques.
• High level of interpersonal communication ability. 
• Good planning and organizational ability on multi tasks.
• Knowledge of the high Quality standard of Japan market.
• Results oriented, entrepreneurial and self-motivating.