Quality Assurance Manager

Sanofi UK

Tokyo, Japan
Cmo quality oversight
Gxp compliance
Batch record review
Drive continuous improvement in CMO manufacturing by managing a portfolio related activities and providing support to CMO management activities like Change Control Requests, leading deviation investigations, and using your findings to deliver positive change

Job Summary

  • Drive continuous improvement in CMO manufacturing by managing a portfolio related activities and providing support to CMO management activities like Change Control Requests, leading deviation investigations, and using your findings to deliver positive change.
  • Responsible for quality oversight of cGMP documents and records including batch production records, validation protocols/reports, product release documentation, change controls, deviations, CAPA, lab investigations, complaint investigations, product quality review, and quality agreements.
  • Sanofi provides equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Matching Summary

Drive continuous improvement in CMO manufacturing by managing a portfolio related activities and providing support to CMO management activities like Change Control Requests, leading deviation investigations, and using your findings to deliver positive change.

Skills & Requirements

Must-have

  • CMO quality oversight
  • GxP compliance
  • batch record review
  • product release
  • deviation investigations
  • CAPA management

Nice-to-have

  • continuous improvement
  • stakeholder management
  • eager to learn
  • attentive to details
  • negotiation skills

Key Requirements

  • Degree in Pharmacy or Chemistry
  • at least 5 years of experience
  • biopharmaceutical manufacturing or QC/QA experience
  • Japanese health authority communication experience

Work Rights

Not specified

Tailored Resume

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