The role involves tracking, maintaining, and analyzing batch records while coordinating finished product release and collaborating across teams to improve batch records
Job Summary
The role involves tracking, maintaining, and analyzing batch records while coordinating finished product release and collaborating across teams to improve batch records.
The engineer will monitor the manufacturing process to identify and resolve quality issues, ensuring compliance and supporting GMP improvements on the shop floor.
Responsibilities include conducting training for new employees, performing external document assessments, and handling quality assurance duties as assigned by supervisors.
Matching Summary
The role involves tracking, maintaining, and analyzing batch records while coordinating finished product release and collaborating across teams to improve batch records.
Skills & Requirements
Must-have
Batch record analysis and maintenance
Production process monitoring
Cross-functional coordination
Quality troubleshooting using RCA and 5WHY
GMP compliance monitoring
Training new employees
Nice-to-have
Proficient in WORD, EXCEL, POWERPOINT
Expertise in domestic and international medical device regulations
Decision making on product impact
Key Requirements
Advanced level of English
Bachelor’s degree or above
3 years or more quality management experience preferred
Familiarity with domestic and international medical device regulatory environment