1.Compliance management
Participate in QC preparation, rehearsal and defense for client audit and regulatory inspection
Participate in laboratory OOS, OOT, and atypical result investigation
Be responsible for maintenance and improvement of lab compliance and data integrity through, e.g. lab walkdown
Support other external visits and inspections related to QC
Be responsible for maintenance and improvement of QC compliance related procedures
2.Support of CDMO projects
Coordinate on QC topics for customer projects
Coordinate customer facing events for QC related activities, e.g. routing meeting with client, and maintain customer relationship
Perform the gap analysis and lab fit for QC operation
Participate in troubleshooting, deviation investigation, CAPA and change control related to QC operation.
3.Metrology management
Execute lifecycle management of instruments and equipment in QC labs
Cooperation with engineering, QV and QA teams on installation, qualification and maintenance of instruments and equipment through lifecycle
Be responsible for maintenance and improvement of metrology management related procedures
Be responsible for lab electronic system management
4.Other QC operation management
Be responsible for QC documentation and training in synergy with QA
Be responsible for QC EHS
Be responsible for QC WBS
Be responsible for QC laboratory maintenance and cleaning
5.Sample management
Maintain sample flow in a compliant and efficient manner, and in synergy with other teams to ensure project delivery
Maintain on-site stability and retention samples, and organize routine inventory check
Be responsible for maintenance and improvement of sample management related procedures
6.Respect and follow EHS and ESG rules
7. Other work assigned by line manager