Quality Compliance - Inspection Readiness & Risk Intern
Core
Support quality compliance, inspection readiness, and risk management activities within External Manufacturing for a pharmaceutical company.
Role type
Intern, Quality Compliance (External Manufacturing)
Builds
Supports day-to-day operations and regulatory alignment for Contract Manufacturing Operations (CMOs) within External Manufacturing.
Domain
Pharmaceutical manufacturing / Quality Assurance / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
Time management, organizational skills, proficiency in Microsoft Office (Word, Excel, Access, PowerPoint), ability to work in fast-paced environments, public speaking, collaboration
Preferred skills
Passion for pharmaceutical sector, innovation in healthcare
Responsibilities
Support compilation and tracking of quality/regulatory performance 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 quality support to Contract Manufacturing Operations; Support continuous improvement and Operational Excellence initiatives; Assist with GMP/regulatory document progression and review; Engage in Quality Culture initiatives; Provide routine administrative support (scheduling, minutes, action logs).
