QA Systems Specialist

1 giorno fa

Varese, Lombardia, Italia Grunenthal Tempo pieno
Overview

In Grünenthal’s Manufacturing & Global Operations, you help safeguard product quality across the value chain by leading change controls, PQR issuance, CAPA-driven improvements, and master data validation. You collaborate with cross-functional teams to ensure regulatory compliance and licensing obligations are met while driving continuous quality improvements. This role offers hands-on QA responsibilities with meaningful impact on patient safety and product excellence.

Retribuzione / Benefits
  • performance-based annual bonus
  • equal employment opportunities
Responsabilità
  • Manage change controls across sites
  • Plan and execute site trainings
  • Issue and revise Product Quality Reviews (PQR)
  • Participate in self-inspections and CAPA management
  • Revise Master Batch Records
  • Issue validation protocols and reports
  • Participate in risk assessment management
  • Cooperate in revising qualification and validation documentation
  • Oversee Quality Agreement with customers
  • Support regulatory activities to maintain manufacturing licenses
  • Collect and monitor site KPIs
Requisiti fondamentali
  • Degree in Scientific disciplines
  • 3–5 years of experience in Quality Assurance within pharmaceutical sector
  • Knowledge of local and international regulatory requirements and GMP standards
  • Competency in communication and interfaces management
  • Fluent English
  • communication
  • stakeholder management
  • team collaboration
  • GMP knowledge
  • regulatory compliance
  • CAPA