Quality Compliance - Regulatory Operations Intern
Core
Support quality compliance, inspection readiness, and risk management for external manufacturing operations.
Role type
Quality Compliance Intern (Regulatory Operations)
Builds
Supports External Manufacturing quality systems and regulatory reporting.
Domain
Pharmaceutical manufacturing / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
Time management, organizational skills, computer proficiency (Word, Excel, Access, PowerPoint), ability to work independently, public speaking, project balancing
Preferred skills
Passion for pharmaceutical sector, innovation in healthcare
Responsibilities
Support compilation and tracking of quality/regulatory metrics; Assist with Regulatory Restriction Forms and regulatory requests; Support change controls, deviations, CAPAs, complaints, audits, and inspections; Prepare regulatory summaries for Annual Product Quality Reports; Provide support to Contract Manufacturing Operations; Support quality projects and continuous improvement; Manage GMP/regulatory documents in the Documentation Management System; Review and approve site procedures; Engage in Quality Culture initiatives; Provide routine administrative support.
Seniority
Intern
