QA Specialist/Senior QA Specialist

Apply for this position

Responsibilities:

  • On behalf of Company QA, ensure cGMP compliance in CMO companies in daily production operations, especially during the time manufacturing APIs and IMPs;
  • Eliminate or at least reduce the deviations, involved in the investigation for OOS and deviations occurred in products; CAPA implementation following up after auditing reports;
  • Familiar with the regulations and GMP requirements in manufacturing process for API synthesis and oral solid dose production;
  • Review and finalize the quality specifications for each API and finished product, eliminating the risk of missing any required testing in quality controls;
  • besides GMP and GLP knowledge, also understand the principle of good scientific practice (GSP) for data authenticity, data accuracy and data safety;
  • Involved in SOP review in non-CMC departments;
  • Good interpersonal and coordination skills;
  • Able to travel for business trip;

Qualification:

  • BS or above in Chemistry, Biochemistry and Pharmaceutical Science
  • 2 years QA experience in international pharmaceutical company
  • CET-6 or above