Responsible for deviation investigation and change control within the department, as well as analysis and review of deviations and CAPA effectiveness to drive continuous improvement
Job Summary
Responsible for deviation investigation and change control within the department, as well as analysis and review of deviations and CAPA effectiveness to drive continuous improvement.
Conduct process flow and data analysis to promote production process optimization and standardization, continuously improving production efficiency and quality.
Support internal and external departmental audits, including preparing audit materials, accompanying auditors, and tracking rectification follow-ups.
Matching Summary
Responsible for deviation investigation and change control within the department, as well as analysis and review of deviations and CAPA effectiveness to drive continuous improvement.
Skills & Requirements
Must-have
Deviation investigation and change control
Risk assessment and compliance
Process optimization and standardization
GMP compliance and operational risk
SHE inspection and issue tracking
Internal project management
Nice-to-have
Continuous improvement initiatives
Cross-departmental collaboration
Data integrity management
Key Requirements
Bachelor's degree or above in Cell Biology, Molecular Biology, Statistics, or related fields
Minimum 3 years of production or QA experience in cell culture, aseptic operation, and related GMP environments
Strong GMP drug production concepts
Practical experience with quality management tools such as deviation investigation, CAPA, and change control
Good documentation writing skills
Good English listening, speaking, reading, and writing skills