仕事内容:
1. Quality Assurance and Document Control based on GMP&QMS(ISO13485) at Buzen Plant
- Execute and support GMP/ISO13485‑based Quality Management System activities (change control, deviations, NC/CAPA, internal audits).
- Lead Data Integrity (DI) programs, including compliance monitoring, improvement planning, and staff training.
- Support regulatory authority audits and manage assigned follow‑up tasks.
- Perform Supplier Quality Management (SQM): supplier registration, change management, audit program planning/monitoring, and KPI reporting.
- Create, revise, and manage GMP/QMS documents.
- Maintain the QDOK document management system and provide user training/support.
- Prepare batch records and manage quality records and validation documentation.
- Handle COA collection for raw materials and support incoming material operations.
- Enter raw material and finished product data into SAP.
- Conduct visual inspections of packaging materials.
- Perform other assigned quality assurance tasks as needed.
- Communicate and collaborate effectively with stakeholders across departments and sites to ensure smooth execution of QA and document control activities.
2. Quality Assurance and Document Control based on QMS(ISO13485) at Inukai Plant
- Execute and support Quality Management System activities related to QMS (e.g., change control, deviation handling, NC/CAPA and internal audit)
- Support regulatory authority audit and handle assigned tasks
- Perform supplier quality management (SQM) activities, including supplier registration and change management, planning and monitoring supplier audit programs, and managing / reporting KPI program
- Create and revise QMS documents
- Maintaining of document management system (QDOK System) and education and support for end users
- Management for Quality Records and Validation Reports
- Perform other quality assurance related tasks as assigned
3. Others
- Communicate and collaborate with stakeholders in a good and appropriate manner as a team in same department/same site/other sites in order to execute works listed above
アピールポイント:
At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision—“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 125,000 employees.
Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.
Our values guide how we work:
- We Care for our patients, each other, and our communities
- We Connect across teams and borders to deliver excellence together
- We Commit to doing things the right way— growing with purpose and leading kidney care with integrity and innovation
求める人材:
Your Profile:
- Capable of communicating in Japanese at a Native level.
- Bachelor’s degree holder with solid proficiency in Microsoft Word and Excel.
- Good understanding of pharmaceutical GMP and medical device QMS (ISO13485).
- Practical knowledge and experience in quality assurance and document control within GMP/QMS environments.
- Capable of communicating in English at a business‑basic level.
勤務時間・曜日:
就業時間：8時30分〜16時45分
特別な事情・期間等：製品のトラブル、大規模なクレーム対応
休暇・休日:
休日
土曜日，日曜日，祝日
その他:
Job Type: Full-time
Pay: 230,000円 - 310,000円 per month
Average number of scheduled working hours (monthly): 160 hour(s)
