M&s-batch Release & Pcu Lead 产品放行和生产制作qa主管-hangzhou

Sanofi UK

Hangzhou, China
Cgmp compliance
Batch release process
Quality assurance principles
Responsible for the batch release, providing QA oversight to ensure that manufacturing stages of the product complies with cGMP and Sanofi global requirement and standard requirements

Job Summary

  • Responsible for the batch release, providing QA oversight to ensure that manufacturing stages of the product complies with cGMP and Sanofi global requirement and standard requirements.
  • Perform oversight for manufacturing steps, include Gemba, inspection, investigation etc.
  • Being representative of the site in the CoP led by the global and if requested participating in the CoE and ensure local communication.

Matching Summary

Responsible for the batch release, providing QA oversight to ensure that manufacturing stages of the product complies with cGMP and Sanofi global requirement and standard requirements.

Skills & Requirements

Must-have

  • cGMP compliance
  • batch release process
  • quality assurance principles
  • investigation and resolution
  • risk assessment implementation

Nice-to-have

  • continuous improvement initiatives
  • cross-functional collaboration
  • driving self-awareness
  • safe working environment

Key Requirements

  • 8 years pharmaceutical industry experience
  • 1 year production management experience
  • 5 years QA work experience
  • 3 years on-site QA operations experience
  • Bachelor’s degree above
  • English speaking, reading and writing

Work Rights

Not specified

Tailored Resume

Cover Letter