Drug Product QP Operations Cruiserath Intern
Core
Support the Qualified Person (QP) with batch certification and release of drug products to ensure patient safety and regulatory compliance.
Role type
Intern, Quality Operations (Drug Product)
Builds
Batch documentation packages and quality records for drug product release
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Microsoft Excel, Microsoft PowerPoint, attention to detail, organizational skills, ability to work independently, ability to manage multiple priorities
Preferred skills
Knowledge of SOPs, familiarity with computerized systems, experience with site inspection readiness
Technologies
Microsoft Office Suite, computerized quality systems
Responsibilities
Prepare and review batch documentation packages for QP release, liaise with supply chain and quality colleagues, update SOPs and controlled documents, assist in new product introduction activities, provide training to new team members, support site inspection readiness, participate in QMS activities (Change Control, Self-Inspections, Complaints), ensure work conforms to regulatory guidelines, support QA Senior Specialists
Seniority
Intern
