Senior Specialist Qc Compliance Support

AstraZeneca

Suzhou, China
Qc sample management
Qc record management
Certificate of analysis (coa) management
Responsible for QC sample management, including drafting sample management procedures; sample receipt, verification, distribution, retrieval, and disposition

Job Summary

  • Responsible for QC sample management, including drafting sample management procedures; sample receipt, verification, distribution, retrieval, and disposition.
  • Comply with the Good Manufacturing Practice (GMP) for Pharmaceutical Products (2010 Edition), the Requirements for Pharmaceutical Records and Data Management (Trial), and company policies on data integrity to ensure data integrity.
  • Conduct QC laboratory compliance inspections and guide teams to complete corrective actions on time.

Matching Summary

Responsible for QC sample management, including drafting sample management procedures; sample receipt, verification, distribution, retrieval, and disposition.

Skills & Requirements

Must-have

  • QC sample management
  • QC record management
  • Certificate of Analysis (COA) management
  • QC document management
  • stability studies management
  • QC reagent and reference standard management
  • abnormality investigations
  • outsourced testing management
  • data integrity ALCOA+CCEA

Nice-to-have

  • embraces diversity and equality
  • inclusive and diverse team
  • harnessing industry-leading skills
  • well-developed interpersonal skills

Key Requirements

  • Bachelor's degree or higher
  • At least three years of experience
  • Proficient in computers and Microsoft software
  • Familiar with GMP regulations
  • Familiar with national pharmacopoeias
  • Familiar with quality management systems
  • English listening, speaking, reading and writing skills

Work Rights

Not specified

Tailored Resume

Cover Letter