RoleQA AssistantLocationBorgo San Michele – Latina, ItalyPurposeFor our manufacturing site in Borgo San Michele (Latina), we're looking for a permanent hire to join the Quality team. Prima di candidarsi per questo ruolo, la preghiamo di leggere le seguenti informazioni su questa occasione, riportate di seguito. The role focuses on ensuring that products comply with national and international pharmaceutical regulations in terms of quality control and documentation. You'll be part of the Quality Assurance team, helping to meet GMP and internal quality standards.ResponsibilitiesPerform all controls required by procedures for second-level approval of Batch Records.Act as Quality Leader/Quality Approver in the management of investigations, ensuring appropriate review and approval of records.Ensure investigations are complete, that compliance and quality impact are properly assessed, and that appropriate corrections and corrective actions are defined and implemented.Investigate complex quality issues (non-conformances)



and ensure appropriate communication within and outside the site; act as Escalation Lead in accordance with the relevant procedure.Ensure that non-standard shipments and shipments under Quarantine are managed in compliance with procedures.Support the different site departments in resolving issues with potential quality impact and actively contribute to the definition of improvement actions.Participate in cross‐functional meetings to define site business priorities and organize team activities in line with defined capacity, ensuring execution of both standard and fast‐track activities.Contribute to the effectiveness and efficiency of the Quality System by monitoring departmental KPIs and implementing appropriate improvement actions where necessary.Actively participate in the department's preparation for regulatory and customer inspections and act as Subject Matter Expert (SME) during inspection execution.QualificationsMaster's degree or diploma in a scient

📌 QA Assistant (Italia)
🏢 7175-Janssen Cilag S.p.A. Legal Entity
📍 Italia