About the job
Core
Support GMP raw material supplier qualification, change control, quality audits, risk assessments, and compliance reviews for a pharmaceutical contract manufacturing organization (CMO).
Role type
Quality Assurance Specialist (Pharmaceuticals)
Builds
Quality management systems and compliance documentation for global CMO customers
Domain
Pharmaceuticals / Quality Assurance
Deliverable
dashboards & analysis
Required skills
GMP knowledge, supplier qualification, change control management, quality audit response, risk assessment, regulatory compliance (Chemical Weapons Convention/Import regulations)
Preferred skills
Business English, QA/QC experience in pharmaceuticals, STEM degree
Responsibilities
Support GMP raw material supplier qualification and change control, respond to quality audits and review quality documents, perform quality risk assessments for new raw materials, review compliance regarding chemical weapons convention and import regulations, manage raw material/supplier suitability for global CMO customer audits