Qc合规工程师

Bion Environmental Technologies Inc

On-site
Gmp laboratory quality control system maintenance
Regulatory compliance with ich q10 and pharmacopoeia
Laboratory record review and data analysis
The role involves establishing and maintaining a GMP-compliant laboratory quality control system including personnel training and document management

Job Summary

  • The role involves establishing and maintaining a GMP-compliant laboratory quality control system including personnel training and document management.
  • Candidates will be responsible for reviewing detection records, ensuring regulatory compliance, and issuing test reports after QA audit.
  • The position requires collaborating with QA and EHS teams to conduct regular inspections and manage corrective actions for identified issues.

Matching Summary

The role involves establishing and maintaining a GMP-compliant laboratory quality control system including personnel training and document management.

Skills & Requirements

Must-have

  • GMP laboratory quality control system maintenance
  • Regulatory compliance with ICH Q10 and pharmacopoeia
  • Laboratory record review and data analysis
  • OOS investigation and deviation management
  • Laboratory instrument and reagent management

Nice-to-have

  • Project management experience in lab settings
  • Strong communication and cross-departmental coordination
  • Experience with biologic or cell product testing
  • High level of English proficiency
  • Commitment to continuous laboratory optimization

Key Requirements

  • Bachelor's degree or higher in Biochemistry, Biological Analysis, or Analytical Chemistry
  • Minimum 3 years of QA experience
  • Minimum 3 years of laboratory work experience
  • Familiarity with global pharmacopoeia and GMP regulations
  • Proficiency in Microsoft Office and English language skills

Work Rights

Not specified

Tailored Resume

Cover Letter