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Quality assurance senior manager

https://www.randstad.com Logo

Randstad

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Location:
Japan, Tokyo

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Category:
Pharmacy

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Contract Type:
Not provided

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Salary:

10000000.00 - 13000000.00 JPY / Year

Job Description:

Ensure quality control, monitoring, and development of systems and procedures across multiple disciplines, leveraging extensive subject knowledge and experience in various quality areas. Manage and oversee quality assurance systems, leading a team of quality professionals to ensure compliance and enhance quality approaches. Perform tasks related to Good Quality Practice (GQP) and Good Distribution Practice (GDP), including SOP creation, contractor management, product shipping, and quality assurance in the distribution process. Collaborate with global departments to gather accurate information from overseas manufacturing facilities, ensuring CMC compliance and GMP review. Handle change management applications for approved products, and prepare appropriate budgets and proposals for quality assurance initiatives.

Job Responsibility:

  • Ensure quality control, monitoring, and development of systems and procedures across multiple disciplines, leveraging extensive subject knowledge and experience in various quality areas
  • Manage and oversee quality assurance systems, leading a team of quality professionals to ensure compliance and enhance quality approaches
  • Perform tasks related to Good Quality Practice (GQP) and Good Distribution Practice (GDP), including SOP creation, contractor management, product shipping, and quality assurance in the distribution process
  • Collaborate with global departments to gather accurate information from overseas manufacturing facilities, ensuring CMC compliance and GMP review
  • Handle change management applications for approved products, and prepare appropriate budgets and proposals for quality assurance initiatives

Requirements:

  • Minimum 5 years work experience in GQP/GMP work at a pharmaceutical company
  • Minimum 5 years of experience in GQP/GMP work for products of biological origin
  • Must have knowledge of pharmaceutical regulations for products of biological origin including GMP and CMC after the amendment in 2005
  • Bachelor’s degree or higher in pharmacy or science major
  • Proficiency in English to communicate with Global staff (conference call, email)
What we offer:
  • 健康保険,厚生年金保険,介護保険,雇用保険,労災保険
  • 日曜日,土曜日,祝日

Additional Information:

Job Posted:
May 01, 2025

Expiration:
August 18, 2025

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:
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