QA Engineer - Process Control

Job description

JOB DESCRIPTION: 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. The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: LOCATION: China > Hangzhou : #198 12th Street, Hangzhou Economic & Technological Development Area ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable