Share this Job

QA Specialist

Beijing, CN

Ref. number:  5022

QA Specialist

 

based in Shanghai

 

PURPOSE OF POSITION

 

  • Better compliance
  • Better and detailed management Quality-related activities
  • Better supporting for other BU functions

 

KEY ACCOUNTABILITIES

  

  • Complaint handling, including receiving, system registering, follow-up and feedback to customer, as well as communication with both customer and global Vigilance team.
  • Label creating, checking, reviewing and approval in required time limit. Communication with third-party out sourcing labeling party.
  • Support activities of third party warehouse as well as other internal BU function.
  • Preliminary PMS vigilance and processing
  • Maintain various authority website account and information of both our company and products.
  • Review qualifications of distributors.
  • QA documentation handling, including various records and SOPs.
  • COA translating
  • Handling administrational affairs of Shanghai Office

 

KEY DECISIONS

 

 

  • Preliminary Label & IFU reviewing
  • Preliminary Adverse Event identification
  • Review qualification of distributor.

 

CAPABILITIES; QUALIFICATIONS AND EXPERIENCE

 

  • Bachelor degree on Medical Device related majors, such as pharmaceutical, medical, nursing, biological science and so on.
  • Excellent EN written and oral communication skills
  • 2 years hands-on QA experience in medical device or drug company
  • Familiar with NMPA GSP-related regulations
  • Highly responsible altitude
  • Manage time effectively, and handle multiple work pressures
  • Ability to solve problems
  • Ability to get along well with different personalities and to work well in teams.
  • Meticulous and patient.