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 sound judgment and timely, risk-based decisions
- Excellent interpersonal and collaboration skills
- Willingness to support growth of QMS and learn continuously
- Experience with pharmaceutical products for rare diseases is a plus
- collaboration
- adaptability
- effective communication
- GDP Quality Management System
- deviations, CAPA, change control
- audits (internal, supplier, customer)
Senior Quality Assurance GDP Specialist datore di lavoro: Chiesi
Lavorare con noi significa essere parte di un team innovativo e dedicato, impegnato a trasformare la salute nelle malattie rare. Offriamo un ambiente di lavoro flessibile e collaborativo, con opportunità di crescita professionale e sviluppo delle competenze nel campo delle evidenze reali. I nostri dipendenti beneficiano di un programma di benessere completo, supporto per il trasferimento e opzioni di lavoro remoto, rendendo la nostra azienda un datore di lavoro eccezionale per chi cerca un impatto significativo nella sanità.
