Quality Systems Specialist
Contact: Alvin Yeo Zong Han (Lic No: R24126316 / EA No: 16S8194)
Quote Job Ref:
Phone Number: +65 6027 2671
Job Advertisement: Quality Assurance Specialist - Life Sciences MNC
Location: Tokyo, Japan
About Us:
We are a global leader in analytical instruments, where precision and excellence meet. Our advanced solutions support critical research in pharmaceuticals, biotechnology, food and beverage, and environmental testing. As part of our team, you will contribute to groundbreaking advancements and work in a dynamic, supportive environment.
Key Responsibilities:
- Assist in maintaining and improving the site Quality Management System (QMS) effectiveness and compliance with global and local regulatory (ie 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 our Japan products and processes with the Quality Agreement between us 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 Japan Commercial Operations objectives.
- Help in representing us in regional, global and/or cross functional teams, projects and initiatives.
Qualifications:
- Bachelor's degree in areas such as engineering, life sciences and chemistry.
- 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.
- 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.
- External: Third party registrar, Regulatory Authority, 3PL.
- Internal: Quality, Regulatory Affairs, Commercial Operations.
- Able to influence direct / indirect stakeholders.
- Able to collaborate effectively across regions.
What We Offer:
- Competitive salary and performance-based incentives.
- Opportunities for professional growth and development.
- A collaborative and innovative work environment.
If you're passionate about ensuring the highest standards in scientific innovation and take pride in safeguarding product quality and regulatory compliance, we'd love to hear from you! Join us in advancing the future of healthcare by upholding excellence in every detail!
Contact: Alvin Yeo Zong Han (Lic No: R24126316 / EA No: 16S8194)
FAQs
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