Quality & Regulatory Associate
Core
Support quality, regulatory, and environmental processes for Henry Schein UK & Ireland, maintaining QMS and EMS document controls and schedules.
Role type
Quality & Regulatory Associate
Builds
QMS and EMS documentation, SOPs, work instructions, and audit schedules
Domain
Pharmaceutical/Medical Device / Quality & Regulatory
Deliverable
dashboards & analysis
Required skills
Document control, Regulatory compliance, ISO 9001/14001 awareness, Good Distribution Practice (GDP), CAPA management, Change Control, Risk Assessment, Data collation, Microsoft Office (Advanced Excel)
Preferred skills
Medical/pharmacy industry knowledge, Training procedure coordination, Intranet system development
Responsibilities
Act as document controller for UK & IE locations, Support completion and publication of SOPs and WIs, Maintain QMS/EMS schedules and audit plans, Coordinate QMS/EMS registers and open actions (Risk Assessments, CAPAs, Deviations, Change Control), Support Management Review process data collation, Maintain electronic and manual filing systems, Support Training procedures and QARA & EMS intranet system development
Seniority
Mid-level, hands-on IC