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Manager - Quality Assurance

Mononuclear Therapeutics Limited

  • Company Industries:Medical / Pharmaceutical

Job Information

  • Post Date:2017-11-14
  • Career Level:Middle
  • Location:Not Specified
  • Salary:Salary negotiable
  • Employment Type:Full Time
  • Job Function:Life Science  Pharmaceutical  Quality Assurance, Control & Testing / ISO  

Job Description

Job Description 

  • Establish and maintain company's Quality Management System (QMS) that meets the requirements and standards of cellular therapy
  • Establish and monitor all processes and procedures for the QMS to comply with the regulatory requirements and accreditation standards
  • Establish and maintain quality documents and records of the production of cellular therapy products
  • Prepare, review, modify, and approve all policies and procedure and other AABB, FACT and GMP controlled documents
  • Provide QMS training to staffs
  • Coordinate both internal and external audits
  • Assist regulatory affairs, accreditations and product registration related activities

 Job Requirements

  • Bachelor degree or above in pharmacy, life science or related science disciplines.  
  • At least 5 years relevant QA experience in cellular therapy, pharmaceutical or related sectors 
  • Knowledge in AABB, FACT, PIC/S GMP
  • Proficient in written and spoken in English and Chinese.   
  • Strong communication and problem solving skills
  • Able to work independently under pressure and detail minded
  • Salary will be commensurate with experience. 

Company Info

Mononuclear Therapeutics situates in Hong Kong Science Park and is dedicated to build stem cell bank using state-of-the-art technology to develop cellular therapies for neurological diseases including spinal cord injury, stroke, macular degeneration.   Based in Hong Kong, the company works closely with universities and industrial partners in Hong Kong, the United States, China and Taiwan.  

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