Overview
The Quality Systems Specialist provides expertise and experience of quality affairs (local regulations, ISO standards, QSM etc.) in Japan, and ,under supervision of Quality Systems Manager, the person assists Quality Systems Manager to support business operations and ensure compliance with MHLW & PMDA regulations and ISO standards.
Responsibilities
- Assist in maintaining and improving the site Quality Management System (QMS) effectiveness and compliance with global and local regulatory (i.e. Japan Pharmaceutical Affairs Law) requirements.
- Help external and internal audits or inspections program to ensure its effectiveness.
- Recording, analyzing and distributing statistical information of quality affairs.
- Maintain and improve the site training and education program ie by ensuring an efficient Learning Management Systems (LMS) and meet applicable standards/requirements.
- Ensure compliance of Waters Japan products and processes with the Quality Agreement between Waters Japan and legal manufacturers.
- Routinely perform compliance assessments on processes, procedures and regulations to identify potential gaps and implement improvements.
- Support Japan leadership team to achieve Waters Japan Commercial Operations objectives.
- Help in representing Waters Japan in regional, global and/or cross functional teams, projects and initiatives.
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Qualifications
Education:
Bachelor's degree in areas such as engineering, life sciences and chemistry.
Experience:
Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials, and food sciences for over 60 years. With approximately 8,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries. Our team focuses on creating business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.
Working at Waters enables our employees to unlock the potential of their careers. Our global team is driven by purpose. We strive to be better, learn and improve every day in everything we do. We're the problem solvers and innovators that aren't afraid to take risks to transform the world of human health and well-being. We're all in it together delivering benefit as one to provide the insights needed today in order to solve the challenges of tomorrow.
Diversity and inclusion are fundamental to our core values at Waters Corporation. It is our responsibility to actively implement programs and practices to drive inclusive behavior and increase diversity across the organization. We are united by diversity and thrive on it for the benefit of our employees, our products, our customers and our community. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or protected Veteran status.