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.
Qualifications:
Education:
Bachelor's degree in areas such as engineering, life sciences and chemistry.
Experience:
* Minimum 5 years of experience in the commercial medical device, diagnostic products or pharmaceutical industry
* Proven experience in supporting third party audits (ISO registrars, PMDA or other regulatory authorities).
* QMS auditor experience.
* Good understanding of PMD Act, relevant regulations and guidelines.
Sklll & Competence:
* Able to collaborate effectively with local and global stakeholders to deliver expected results to Waters.
* Able to work efficiently with minimum supervision.
* Able to work within a matrix organization.
* Languages: Native Japanese, Business English - reading and writing.
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