Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Development

Testing

Discovery

Antibody Drug Conjugates

Technologies & Platforms

Responsibilities

  • Oversee the quality of QA online and QA release group.
  • Act as QA Function leader for client projects
  • Key contact person for the discussion of Quality Assurance Agreement with clients
  • Actively involved in the communication with client regarding Quality activities conducted in the facility (such as deviation, change control, OOS, batch release etc.)
  • Timely transfer client comments/suggestion to each functional department.
  • Responsible for the creation, revision, and training on client management SOPs
  • Responsible for GMP regulation/guidance monitoring and internal updating
  • Other tasks assigned by the supervisor

 

 Basic Qualifications:

  • At least 5 years working experience in QA area or production manufacturing; Biopharmaceutical or Sterile product manufacturing experience is preferred.
  • Biotechnology, Pharmacy or related
  • Bachelor degree and above
  • Good in English, Fluent in spoken and written

 

Primary Location: China – Wuxi

To apply please send your application to HR_Biologics@wuxiapptec.com

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