The role ensures that operations in environmental monitoring fulfill all GMP requirements while preparing relevant specifications and analytical test methods
Job Summary
The role ensures that operations in environmental monitoring fulfill all GMP requirements while preparing relevant specifications and analytical test methods.
Candidates will be responsible for projects, continuous improvement, validation, and investigations related to sterility assurance and contamination control strategies.
The position requires active participation in audits as a Sterility Assurance Subject Matter Expert and collaboration with production and engineering departments.
Matching Summary
The role ensures that operations in environmental monitoring fulfill all GMP requirements while preparing relevant specifications and analytical test methods.
Skills & Requirements
Must-have
3+ years QA/SA experience in sterile products
Knowledge of Chinese and international GMP
Microbiology analytical methodologies expertise
Contamination Control Strategy (CCS) implementation
GMP compliance for environmental monitoring
Nice-to-have
Problem-solving oriented mindset
Strong communication and cooperation skills
Experience with validation and investigation
Ability to lead technical training deployment
Fluency in English for global collaboration
Key Requirements
B.S. degree in Chemistry, Pharmacy, Biology, or Microbiology
Minimum 3 years of QA/SA experience for sterile products
Proficiency in English listening, writing, and speaking