Overview In this role, you will safeguard product quality across QA systems and GMP processes at the Goa site. You will collaborate with cross-functional teams to manage quality reviews, deviations, CAPAs, and validation activities, ensuring compliance with ICH/GxP standards. Your work supports fast, safe delivery of life-changing medicines at scale. This position offers a hands-on role in quality governance within a global biopharma network, leveraging data and processes to improve compliance and product quality. You will be a focal point for IPQA, change controls, and QA oversight on the shop floor, enabling reliable batch release and continuous improvement. Responsabilità * Manage Quality Systems including Product Quality Reviews, Change Control, Deviation, Market Complaint investigations, and CAPA. * Act as QA focal point for OOS/OOT management and ICHQ3D requirements. * Coordinate implementation of Sanofi Global Standards (STDs) and Global Operating Procedures (GOPs). * Oversee Subcontractor/Service Provider management and various validation systems (process, cleaning,
transport, computerized systems). * Support training, document control, data integrity, audit trails, and archival/retrieval. * Lead batch release activities and respond to QP queries; manage Master/Batch Records review and line clearance. * Participate in self-inspections, GMP training, and cGMP documentation review. * Act as Site Master File custodian and support HSE activities and SMS initiatives. * Oversee Calibration document reviews and user access management; support nitrosamine assessment and QA studies. * Coordinate IPQA activities including in-process checks, sampling, and shopfloor quality oversight. Requisiti fondamentali * 2 to 5 years of experience * B.Pharm / M.Pharm * Experience in IPQA, Batch Record Review, and Shopfloor Quality Governance * cross-functional collaboration * attention to detail * strong communication * IPQA * Batch Record Review * GxP document review
📌 Quality Assurance Specialist (Italia)
🏢 Sanofi
📍 Italia