Description
By joining us you will be part of a global biopharmaceutical company dedicated to improving people's health. We foster a diverse and inclusive environment where individuals can unlock their potential and work towards a brighter future. Are you ready to make a difference in the world?
At our Quality System & Compliance Group, we oversee the quality systems at the Narita plant ensuring compliance with GMP regulations. Our focus includes document management, training, supplier control, validations, complaint investigations, and regulatory inspections. Join our team and contribute to delivering top-quality products nationally and internationally.
Responsibilities
We will assign you tasks based on your experience and skills:
"Quality System"
- Document management
- Training
- Change management
- Validation program management/improvement
- Data integrity management
- IT system management
"Quality Compliance"
- Regulatory inspections management
- Responses to inquiries from regulatory authorities
- Quality KPI/Metric management
- Product quality review management
- Self-audit
Requirements
We are looking for candidates with a minimum of 3 years of experience in pharmaceutical quality assurance under GMP or GXP. A degree in pharmaceuticals, engineering, science, or related fields is desirable, as well as knowledge of regulatory guidelines and strong analytical skills. Fluency in English (TOEIC 600 points or above) is a must.
Compensation and Benefits Summary:
- Allowances: Commutation, Housing, Overtime Work, etc.
- Salary Increase: Annually, Bonus Payment: Twice a year
- Working Hours: Flexible schedules
- Holidays: Generous paid leave benefits
- Benefits: Social Insurance, Retirement Plan, Stock Ownership
Important Notice:
- Job scope and workplace may change at the company's discretion
Locations: JPN - Chiba - Narita Plant
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full-time
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