ワクチン無菌性保証グループ　課長代理 / Vaccine Sterility Assurance Group, Manager

Takeda

Hikari, Japan
Sterility assurance
Environmental monitoring
Gap analysis
The Vaccine Sterility Assurance Group is newly established to ensure product sterility and contribute to patients and society by understanding and implementing global standards for sterility assurance and environmental monitoring

Job Summary

  • The Vaccine Sterility Assurance Group is newly established to ensure product sterility and contribute to patients and society by understanding and implementing global standards for sterility assurance and environmental monitoring.
  • Responsibilities include performing gap analysis of guidelines and regulations, participating in CAPA planning and execution with manufacturing departments, and evaluating changes for their impact on product sterility.
  • The company offers various allowances, annual salary increases, twice-yearly bonuses, and a comprehensive benefits package including social insurance, retirement plans, and flexible work styles.

Matching Summary

The Vaccine Sterility Assurance Group is newly established to ensure product sterility and contribute to patients and society by understanding and implementing global standards for sterility assurance and environmental monitoring.

Skills & Requirements

Must-have

  • Sterility Assurance
  • Environmental Monitoring
  • Gap Analysis
  • CAPA Planning and Execution
  • Quality System Usage

Nice-to-have

  • Proactive learning attitude
  • Good communication skills
  • Leadership and teamwork

Key Requirements

  • Experience in environmental monitoring sampling
  • Experience with EMRA/EMPQ/EMRQ
  • Experience in sterile environment operations
  • Experience with Quality Systems (Trackwise, Veeva)
  • Proficiency in MS Office (Excel, Word, PowerPoint)
  • TOEIC 500 or higher is desirable
  • Actively working on improving English ability

Work Rights

Not specified

Tailored Resume

Cover Letter