QA for QC Engineer/Senior Engineer

Job Responsibility:

Assist QA for QC Lead to support the establishment of quality management system of QC department and the future oversight of operation/maintenance
Participate in the investigation of lab deviation/OOS/OOT/MDD etc., and support review the investigation report;
Support the qualification activities of instrument/equipment in QC area, such as qualification protocol review;
Support the analytical method transfer, qualification/verification and validation etc. relevant documents review;
Support all QC relevant document/record review relevant with Client project;
Support the analysis report and original data/record review of material/product release;
Support the answering and audit response to client audit/regulatory inspection in QC area, the development of CAPA plan and oversight the implementation and effectiveness evaluation;
Support the client IND documents submission, responsible for the data/information review input by QC.
Other works assigned by the QA head

Education background: Bachelor degree or above, major in pharmacy, chemistry, pharmaceutical engineering or related
At least 4 years working experience in QA department of pharmaceutical company, experience in on-site management of QA for QC is preferred；
Good capability of Microsoft Excel, PPT, Word, etc.
Good organization, coordination, communication and planning skills, good reading and writing skills in English, good oral English is preferred;
Strong sense of teamwork, proactive and enthusiastic, able to work under great pressure and have a high sense of responsibility.