Experteer 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 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 3 PL/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 Responsabilità 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 sound judgment and timely, risk‐based decisions Excellent interpersonal and collaboration skills Willingness to support growth of QMS

📌 Senior quality assurance gdp specialist (Italia)
🏢 Experteer Italy
📍 Italia