TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

Transcenta, biologics, antibody

TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company

contact 中文

Manager, Floor QA

Department :  TechOps
Working place :  Hangzhou
Recruitment :  1
Nature of work :  Full-time
Working years of :  More than eight years
Minimum academic :  Bachelor's degree and above
Release time :  16 Oct, 2020
Responsibilities
  • 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.

Qualifications
  • 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.