23 ott - Trieste
Sanofi
pIn 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. /pulliManage and coordinate Quality Systems, including Product Quality Reviews, Change Control, Deviation, Market Complaint, OOS/OOT, Training, and CAPA systems /liliCoordinate Subcontractor/Service Provider QA activities and ensure alignment with global standards (STDs and GOPs) /liliOversee Validation systems (Process, cleaning, transport, computerized systems) and Calibration document reviews /liliPerform batch release support and respond to QP queries; ensure data integrity and audit trail review /liliLead cGMP document control, training coordination, and self-inspection activities /liliAct as Primary Process Owner for Quality Maturity Index (QMI) and support SMS and HSE initiatives /liliOversee Site Master File,
instrument checks, and documentation archival/retrieval /liliIn-Process Quality Assurance tasks including Master Batch Records review, line clearance, and on-floor quality oversight /liliTemperature/Humidity mapping, hold time studies, and validation/qualification focal points /liliHSE adherence, safe working conditions, and zero-risk safety initiatives /liliReview and approve manufacturing records and logbooks; ensure proper documentation control and access management /liliSupport for Market Complaints investigations and CAPA implementation /liliBatch release processing and data integrity related activities /liliQuality oversight of shopfloor and routine production sampling /lili2 to 5 years of experience in QA/QC environments /liliExperience in IPQA, Batch Record Review, and Shopfloor Quality Governance /liliB.Pharm or M.Pharm /lili3-shift work availability /lilicross-functional collaboration /liliproblem-solving orientation /liliIPQA /liliBatch Record Review /liliShopfloor Quality Governance /li /ulpQuality Assurance Specialist • trieste, friuli venezia giulia, it /p #J-18808-Ljbffr
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