MQA Engineer

MAIN PURPOSE OF ROLE

• Batch Record review and finished product release
• Track and analyze the production trend, to improve the efficiency of batch record and production performance
• To monitor the manufacturing process timely catching up any issues during production, and communicate with cross functions for the trouble shooting from quality standpoint, making sure the compliance status of execution
• Onsite monitoring and improve of manufacturing shop floor GMP

Main Responsibilities

• Track, maintain and analyze the batch record, cooperate with cross team for the improvement opportunity of batch record, and coordinate for finished product release.
• To monitor the manufacturing process timely catching up any issues during production, and communicate with cross functions for the trouble shooting from quality standpoint, making sure the compliance status of execution.
• On line quality management for production, and develop proper procedure to guide the new issues according to actual production. Online monitoring for manufacturing shop floor GMP, supporting & following the improvement.
• Coordinate with cross departments for the trouble shooting, like work order, manufacturing, packaging and so on.
• Individually evaluate the impact of the finished product, and be a decision maker.
• Perform external document assessment.
• Observe issues independently, and trouble shooting for them by using quality tools, like RCA and 5WHY.
• Undertake other quality assurance responsibilities.

Qualifications

• Education : Bachelor Degree and above in f or related discipline or Diploma
• 3+ years’ quality experience in pharmacy or medical devices industry
• Other qualifications/certifications :
• Familiar with the regulation code of ISO9000, ISO13485, GMP, 21CFR820, IVDD, IVDR Regulation， etc. FDA audit experience is preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects.
• Strong organizational, communication and coordination skills, as well as attention to detail.