QA Engineer Process Control
Share
Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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/AIn 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
Key Skills
- Food Safety
- Babysitting
- Business Management
- ABAP
- Domestic
- Automobile Service
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
