M&s-sterility Assurance Senior Specialist-beijing

Sanofi UK

Beijing, China
Fully remote
Environmental monitoring gmp
Contamination control strategy
Microbial assessment sops
To ensure the operations in environmental monitoring fulfill the GMP requirement

Job Summary

  • To ensure the operations in environmental monitoring fulfill the GMP requirement.
  • Be responsible to projects and continuously improvement, validation and investigation in EM and sterile assurance.
  • Participate in the investigation for sterility/microbe contamination issue in EM, equipment, utility, material, product, APS etc.

Matching Summary

To ensure the operations in environmental monitoring fulfill the GMP requirement.

Skills & Requirements

Must-have

  • Environmental monitoring GMP
  • Contamination control strategy
  • Microbial assessment SOPs
  • GMP and Pharmacopeia requirements
  • Sterility/microbe contamination investigation

Nice-to-have

  • Problem solving oriented
  • Good communication and cooperative ability
  • Play to Win Behaviors

Key Requirements

  • Minimum 3 years QA/SA experience
  • Microbiology analytical methodologies
  • Chinese and international GMP knowledge
  • B.S. degree or above
  • Good English listening, writing and spoken

Work Rights

Not specified

Tailored Resume

Cover Letter