成田工場　品質管理試験G　品質試験者

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Job Description

At the Narita Plant, the individual will be responsible for the following activities related to raw materials, intermediates, and finished products for plasma‑derived products:

• GMP-compliant testing
  Conduct physicochemical testing in accordance with SOPs.
• Testing related to pharmacopoeias and regulatory filings
  Perform testing in compliance with the Japanese Pharmacopoeia and the Minimum Requirements for Biological Products. When changes occur in pharmacopoeial or filing-related test requirements, carry out verification and revise procedures as needed.
• Validation of analytical and test methods
  Perform analytical and test method validation for newly established test methods and newly introduced equipment.
• Foreign matter analysis in processes and products
• Support during inspections and audits
• A bachelor’s degree or higher in Pharmacy, Engineering, Science, Agriculture, or a related field. Approximately three or more years of experience in at least one of the following areas related to pharmaceutical quality control (physicochemical testing of injectables, antibody, or biologics products).
• Work experience (one or more of the following):
  Experience in quality control operations within a manufacturing department
  Experience in testing activities in a CMC research department
  General knowledge of pharmaceutical testing (manufacturing)
  Hands-on experience in managing pharmaceutical testing operations
• Other requirements
  Proficiency in Microsoft Office applications (Excel, PowerPoint, Word)

Takeda Compensation and Benefits Summary:

• Allowances: Commutation, Housing, Overtime Work etc.

• Salary Increase: Annually, Bonus Payment: Twice a year

• Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45

• Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)

• Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.

• Flexible Work Styles: Flextime, Telework

• Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

Important Notice concerning working conditions:

• It is possible the job scope may change at the company’s discretion.

• It is possible the department 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