QA Specialist I
Core
Ensure quality compliance across manufacturing operations and manage documentation for product release and process monitoring in the CTD Andean Region.
Role type
Quality Specialist I (QA)
Builds
Ensures adherence to Good Storage and Distribution Practices (GSP) and Good Manufacturing Practices (GMP) for pharmaceutical products.
Domain
Pharmaceutical manufacturing and distribution
Deliverable
client delivery
Required skills
GMP standards knowledge, regulatory compliance, documentation review and approval, quality management systems (CAPA, change control), process monitoring
Preferred skills
Pharmacist, Chemistry, Biology, or Engineering background
Technologies
IT/administrative tools for quality management
Responsibilities
Manage SOPs, perform product release support, monitor processes, file and update documentation, ensure compliance with GSP/GMP standards for Third Party Depots in Chile, Colombia, and Peru
Seniority
Entry-level (1+ years experience)