In this role you ensure product quality and regulatory compliance within Sanofi's Manufacturing & Supply network. You will coordinate and own quality systems, inspections, and deviations to support reliable, safe medicines at scale. You'll interact with cross-functional teams to implement global standards and drive quality improvements. This is a hands-on position with a focus on end-to-end quality governance and continuous improvement, aligned with Sanofi's mission to deliver life-changing treatments.La preghiamo di verificare di possedere il livello di esperienza e le qualifiche adeguate leggendo la panoramica completa di questa occasione qui sotto.Manage and coordinate Quality Systems, including Product Quality Reviews, Change Control, Deviation, Market Complaint, OOS/OOT, Training, and CAPA systemsCoordinate Subcontractor/Service Provider QA activities and ensure alignment with global standards (STDs and GOPs)Oversee Validation systems (Process, cleaning, transport, computerized systems) and Calibration document reviewsPerform batch release support and respond to QP queries; ensure data integrity and audit trail reviewLead cGMP document control, training coordination,



and self-inspection activitiesAct as Primary Process Owner for Quality Maturity Index (QMI) and support SMS and HSE initiativesOversee Site Master File, instrument checks, and documentation archival/retrievalIn-Process Quality Assurance tasks including Master Batch Records review, line clearance, and on-floor quality oversightTemperature/Humidity mapping, hold time studies, and validation/qualification focal pointsHSE adherence, safe working conditions, and zero-risk safety initiativesReview and approve manufacturing records and logbooks; ensure proper documentation control and access managementSupport for xysqume Market Complaints investigations and CAPA implementationBatch release processing and data integrity related activitiesQuality oversight of shopfloor and routine production sampling2 to 5 years of experience in QA/QC environmentsExperience in IPQA, Batch Record Review, and Shopfloor Quality GovernanceB.Pharm or M.Pharm3-shift work availabilitycross-functional collaborationproblem-solving orientationIPQABatch Record ReviewShopfloor Quality GovernanceQuality Assurance Specialist
- trieste, friuli venezia giulia, it

📌 Quality Assurance Specialist (Trieste)
🏢 Sanofi
📍 Trieste