CSCQ - QA Support Intern
Core
Support Qualified Person disposition processes, packaging/labeling, use date extensions, and quality investigations for Investigational Medicinal Products in clinical trials across EU and Asia/Pacific.
Role type
QA Support Intern (Clinical Supply Chain)
Builds
Quality Management System procedures, supply chain flow maps, product specification files, and Quality Agreements.
Domain
Biopharmaceuticals / Clinical Supply Chain / Quality Assurance
Required skills
GMP/GDP knowledge, deviation investigation, CAPA tracking, document review, regulatory compliance, quality culture engagement
Preferred skills
Chemical/Pharmaceutical/Biomedical background, continuous improvement mindset, cross-functional collaboration
Technologies
Documentation Management Systems, Quality Management Systems
Responsibilities
Support Qualified Person disposition for IMPs, assist in packaging and labeling activities, provide QA support for use date extensions, investigate non-conformances and quality incidents, prepare and review procedural documents, contribute to QMS maintenance, create supply chain flow maps and product specs, support site inspection readiness.
Seniority
Intern