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Quality

CQ assistant manager

  • Job Title CQ assistant manager
  • Function Quality
  • Sub Function Compliance
  • Location Shanghai, China
  • Date Posted
  • Requisition Number 2206084658W
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Description

PURPOSE
Why the position exists? The main function of the position    
•    Assist, coordinate and support all aspects of QA activities as required. 
WORKING RELATIONSHIPS
Internal and external contacts.
Internal contacts: 

  • Marketing Team, Sales Team, Supply Chain Team, RA Team

External contacts: 

  • HA, Suppliers and related associations, customer

KEY ACCOUNTABILITIES
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.
     

Qualifications

REQUIREMENTS

  • 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.
     

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