Tasks performed regularly which form the essential characteristics of the position.
ØProvide design Quality Assurance in project team as assigned.
ØLead design transfer quality part from R&D to Plant and provide guidance to ensure successful design transfer per project plan.
ØResponsible for CFDA license application support, specially focus on R&D preparation of GMP inspection, design transfer, DHF completeness, etc.
ØTo be a DQA and provide Design Assurance Control for quality activities of design change control, complaint handling, CAPA, post market quality data collection and statistics after the products launched via plant.
ØProvide sustaining in Plant:
-Review AMD product NCs;
-Review AMD product CAPAs;
-Review AMD product design changes;
Document and provide evaluation from GRD side.
ØQA team interface with CS plant and cooperate closely with partners and support to produce a good quality product in site.
ØSupport QMS Management and optimize the interface processes in practice between GRD and plant, like design transfer process, design change process, complaint handling process, etc..
ØSupport the preparation of internal and external audit.
ØEstablishing positive and professional team culture within the team.
ØProactively driving project progress for successful delivery.
ØTracking and reporting of project progress.
ØProviding professional knowledge and experience to support product registration.