上海招聘

This position will be based in Changshu City, and frequently travel to Shanghai

Tasks performed regularly which form the essential characteristics of the position.

? Provide design Quality Assurance in project team as assigned.

? Lead design transfer quality part from CDC PEC.COM to GMQ CS Plant and provide guidance to ensure successful design transfer per project plan.

? Responsible for CFDA license application support, specially focus on R&D preparation of GMP inspection, design transfer, DHF completeness, etc.

? To 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 GMQ CS plant.

? Provide sustaining in GMQ CS Plant:

-Review AMD product NCs;

-Review AMD product CAPAs;

-Review AMD product design changes;

Document and provide evaluation from GRD side.

? QA team interface with CS plant and cooperate closely with GMQ CS partners and support to produce a good quality product in GMQ CS site.

? Support QMS Management and optimize the interface processes in practice between GRD CDC and GMQ CS plant, like design transfer process, design change process, complaint handling process, etc..

? Support the preparation of internal and external audit.

? Establishing positive and professional team culture within the team.

Secondary tasks:

? Proactively driving project progress for successful delivery.

? Tracking and reporting of project progress.

? Providing professional knowledge and experience to support product registration.

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