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QA Dept. Head- STA JS

This position is based in Shanghai-JS, China, reporting to QA/QC Executive Director at WuXi AppTec.

Job responsibilities include but not limited to:

  • Review and approve all quality related procedure documents and quality manual according to GMP regulations. 
  • Establish, optimize and maintain the company quality system, ensure the regulator compliance and operability.
  • Define effective CAPA, ensure a continuous quality system improvement by deviation investigation, quality incident handling, product quality review, self-inspection and external GMP inspection.. 
  • Ensure good communication with clients and authority, maintain company quality imagination.
  • Follow client quality agreement, meet client quality expectation.. 
  • Receive client auditing and authority inspection, respond the audit report and follow up the actions.
  • Review and approve VMP and validation documents, ensure that the company validation activities meet GMP requirement.. 
  • Organize quality training, increase the quality awareness of employees.
  • Fulfill QP responsibility as SFDA requirement. 

Qualifications:

  • Major in pharmacy/chemistry, bachelor degree or above. 
  • Very known the production/inspection & QA management in Pharmaceutical industry, familiar with GMP requirements. 
  • Strong communication and presentation skill. 
  • Fluent in English both oral and written.