Overview In this Senior GDP QA Specialist role, you will own key GDP QA activities in a dynamic pharmaceutical setting, ensuring regulatory compliance and business continuity. You will manage core quality processes and drive risk-based decisions to uphold product quality and patient safety. You will collaborate with internal and external stakeholders to strengthen the GDP Quality Management System and support inspections and quality metrics. This position offers autonomy, impact on end-to-end distribution, and opportunities to shape continuous improvement in a global supply network.
Retribuzione / Benefits
pension
private medical insurance
wellbeing programme
flexible benefits programme
relocation support
remote work options
Responsabilità
Define and improve GDP-aligned Quality Systems
Manage deviations, CAPA, change control, and audits (internal, supplier, customer)
Handle distribution complaints, supplier qualification, and QTA with customers/suppliers
Oversee shipping/transport validation and record retention
Support investigations, corrective action effectiveness checks,



and risk management documentation
Support recall operations and management of returned/rejected/recalled/falsified products
Review temperature excursions for release decisions and oversee GDP-related subcontracted activities
Assist regulatory inspections and 3PL/customer audits
Participate in defining quality metrics and represent the GDP department in meetings
Perform Responsible Person duties when required and deputize for GDP QA Manager as needed
Requisiti fondamentali
Qualification in a scientific or technical discipline and /or more than 8 years relevant industry experience
Knowledge of Quality standards and Regulatory guidelines for pharma/biotech products
Experience in conducting Quality activities as described
Experience in project management, analytical skills, and problem-solving
Good prioritization capabilities and adaptability to changing priorities
Ability to work autonomously with

📌 Quality Assurance Specialist Production (Italia)
🏢 Chiesi
📍 Italia