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Clinical Operations and Regulatory Affairs, Suzhou | 30 Sep 2021

QC Chemist

Position QC Chemist
Department QC
Location Suzhou

 

Primary

  • Responsible for Chemical test in QC laboratory

 

Principle Roles & Responsibility

  • Strictly follow the relevant standard operating procedures and testing method procedure of laboratory;
  • Execute the release testing of raw materials, packaging material, intermediate products and finished products, and initiate the relevant testing reports.
  • Execute the finished product stability testing, and initial the relevant stability reports.
  • Initial and revise the chemical test methods and specifications for all materials (including raw materials, excipients and packaging material), intermediate products and finished products;
  • Initial and revise the protocol of method transfer and validation for chemical testings;
  • Execute method transfer and validation according to protocol, initial and review the validation report accordingly;
  • Initial and revise the standard operating procedures for relevant equipment, instruments, reagents, test solution, reference standards and volumetric solutions;
  • Initial and revise the validation protocol for laboratory chemical analysis instruments; cooperate in the qualification/validation, maintenance and calibration of instruments used for chemical testing.
  • Responsible for the chemical testing for utility qualification, key production equipment qualification, product process validation and cleaning validation;
  • Report the OOS results, and conduct laboratory investigation per line manager instruction;
  • Provide specific information when communicating with government drug testing agencies;
  • Responsible for the safety, health and environmental protection (EHS) of itself position;
  • Complete other tasks assigned by line manager.

 

Qualification and Experience

  • College degree or above in pharmacy relevant major;
  • 2 years of relevant work experience;
  • With good physical and chemical testing skills and knowledge;
  • Familiar with chemical laboratory procedures, laboratory instrument operation and regulatory requirements;
  • Experience with chemical method validation is preferred;
  • Experience with USP and EP is preferred.

If interested, please forward your resume to joycej@hutch-med.com