Quality Specialist - Training

26 ott - Trieste
Sanofi

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. ~ Manage and coordinate Quality Systems, including Product Quality Reviews, Change Control, Deviation, Market Complaint, OOS/OOT, Training, and CAPA systems ~ Coordinate 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 reviews ~ Perform batch release support and respond to QP queries; ensure data integrity and audit trail review ~ Lead cGMP document control, training coordination, and self-inspection activities ~ Act as Primary Process Owner for Quality Maturity Index (QMI)



and support SMS and HSE initiatives ~ Oversee Site Master File, instrument checks, and documentation archival/retrieval ~ In-Process Quality Assurance tasks including Master Batch Records review, line clearance, and on-floor quality oversight ~ Temperature/Humidity mapping, hold time studies, and validation/qualification focal points ~ HSE adherence, safe working conditions, and zero-risk safety initiatives ~ Review and approve manufacturing records and logbooks; ensure proper documentation control and access management ~ Support for Market Complaints investigations and CAPA implementation ~ Batch release processing and data integrity related activities ~ Quality oversight of shopfloor and routine production sampling ~2 to 5 years of experience in QA/QC environments ~ Experience in IPQA, Batch Record Review, and Shopfloor Quality Governance ~ B.Pharm or M.Pharm ~3-shift work availability ~ cross-functional collaboration ~ problem-solving orientation ~ IPQA ~ Batch Record Review ~ Shopfloor Quality Governance Quality Assurance Specialist • trieste, friuli venezia giulia, it

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