Quality Assurance Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8f8218

Overview 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. Responsabilità * 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 Requisiti fondamentali * 2 to 5 years of experience in QA/QC environments * Experience in IPQA, Batc

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8f8218