Contract Logistics Quality Specialist Healthcare

8 ore fa

Siziano, Lombardia, Italia Kühne + Nagel Tempo pieno
Overview

In this role you will ensure regulatory compliance and quality excellence within a pharmaceutical logistics context. You work closely with a technical quality team to maintain GXP-compliant systems, manage permits, and support regulatory submissions. You will drive CAPA execution, update procedures, and contribute to process innovation. This position offers a stable environment with growth opportunities and international exposure.

Retribuzione / Benefits
  • safe and stable environment
  • focus on physical and mental well-being
  • professional growth opportunities
  • international opportunities
Responsabilità
  • Ensure import/export permits align with customer requests and timely regulatory notifications to health authorities
  • Maintain and implement a compliant quality management system per site authorizations and product-specific requirements
  • Approve and manage CAPA plan execution
  • Ensure temperature monitoring of warehouse and critical systems remains GXP-compliant
  • Update and approve procedures and operating instructions to support all processes
  • Participate in process reviews to push for quality process innovation
  • Support regulatory documentation preparation for AIFA and other bodies
Requisiti fondamentali
  • Qualified Person (Dlgs 219/2006 and amendments)
  • Responsible Person at pharmaceutical site
  • Master in Biology
  • 5+ years in similar roles
  • Excellent use of Excel and data analysis
  • Advanced English
  • Driving license and own car
  • Time flexibility during induction
  • Excel and data analysis
  • GXP/compliance
  • Quality management systems
  • CAPA
  • Regulatory documentation preparation
  • AIFA/regulatory submissions