Why the position exists? The main function of the position
• Assist, coordinate and support all aspects of QA activities as required.
Internal and external contacts.
- Marketing Team, Sales Team, Supply Chain Team, RA Team
- HA, Suppliers and related associations, customer
Describe in order of relative importance. In listing principal accountabilities emphasize, where appropriate.
List 4 – 10 of the major and result the position is to accomplish.
- Maintain quality system per NMPA medical device GSP regulation and J&J internal request and perform the quality training.
- Conduct supplier/ customer / product license qualification, support to manage master data in system and maintain data in NMPA traceability system
- Support and supervise 3rd party to manage relabelling centre and distribution centre for incoming medical devices (direct sale business) prior to their release to the Chinese market.
- Lead to audit GxP supplier, and distributor etc.
- Support to coordinate internal and external audit e.g.: unannounced audit etc.
- Be responsible for the field action or product recall internal coordination, support external communication and reporting NMPA;
- Support inquiry on GxP compliance and internal quality control from NMPA, customer and etc.
- Closely cooperate with global function, oversea manufacturing sites and local cross functions to support local business needs
- Identify the current operation process and lead the improvement project.
- Other tasks assigned by manager.
- Skills, education, experience or other qualifications which would be required for anyone who would fill the job.
- Education Requirement: University graduate with background related to pharmacy, biotechnology, medical devices, medical, nursing, optics, optometry, optometry Technology and others etc.
- Industry experiences: A minimum of 3 years in the medical device or pharmaceutical industry.
- Position experiences: experience in GSP. Preference manufacturing site, GMP working experience, audit and ISO 13485.
- Language Skills: English level is at or above CET-6 , skilled in oral and written English.
- Computer Skills: Familiar with the MS software, knowledge of Excel for the data analysis, power point for the monthly presentation, SAP experiences is preferred
- Other Special requirement: Strong in skills for communication with different parties, independent problem-solving ability, self-driving, active to learning and manage change etc.