Review and approve QMS documents related to production area;

Review and approve master batch records;

Review production batch records;

Participate in investigation of deviations related to production area, and follow up implementation and effectiveness check of CAPA;

Walk though production areas;

Prepare GMP training courses and implement training;

Participate internal audits;

Hand authority inspections and CDMO client audits;

Participate CQV activities;

Lead floor QA team.

Bachelor degree or above in biology, chemistry, pharmaceutical engineering or other related majors;

At least 8 years’ experience in pharmaceutical industry, including QA;

Good at Chinese and English language skills;

Aseptic and/or biologics production experience is preferred;

FDA, EMA inspection experience is preferred.