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.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
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 management
abnormality investigations
QC outsourced testing management
GMP compliance
data integrity ALCOA+CCEA
Nice-to-have
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
Familiar with guidance on sample management
Familiar with guidance on document management
Familiar with guidance on stability studies
Familiar with guidance on OOS
English listening, speaking, reading and writing skills