Production process optimization and standardization
The role is responsible for managing deviation investigations, change control, and CAPA effectiveness analysis to drive continuous improvement within the manufacturing department
Job Summary
The role is responsible for managing deviation investigations, change control, and CAPA effectiveness analysis to drive continuous improvement within the manufacturing department.
The position supports audit preparation, risk assessments, and compliance system building to ensure GMP adherence and production quality.
The candidate will manage training programs, support contract affairs, and participate in cross-functional projects to optimize production efficiency and quality.
Matching Summary
The role is responsible for managing deviation investigations, change control, and CAPA effectiveness analysis to drive continuous improvement within the manufacturing department.
Skills & Requirements
Must-have
GMP compliance and risk management
Deviation investigation and CAPA analysis
Production process optimization and standardization
Quality management documentation drafting
Internal and external audit support
Cross-departmental project collaboration
Nice-to-have
Team collaboration and communication skills
Problem solving abilities
English proficiency in reading and writing
Key Requirements
211 university degree or above in cell biology, molecular biology, statistics or related
Minimum 3 years experience in cell culture, aseptic operations, GMP production or QA
Strong GMP pharmaceutical production concepts
Experience with deviation investigation, CAPA, and change control quality tools
Proficient document writing skills for SOPs and batch records
Good English listening, speaking, reading, and writing skills