OverviewIn this role you support quality oversight in manufacturing, ensuring GxP compliance and robust collaboration between Quality and Production. You review batch records, manage events, and drive improvements through CAPA to strengthen GMP adherence. You will help maintain GMP documentation and contribute to development projects that deepen production knowledge. Join a quality-focused team that enables safe, compliant production and reliable product quality.

Responsabilità

Review and ensure the execution of quality batch record review in compliance with SOPs and regulationsOpen and manage events identified during batch record review and/or reported by production operatorsReview production procedures and master batch recordIdentify improvement opportunities and implement CAPA to increase GMP compliance in production areasActively collaborate with Production to identify and resolve compliance gaps,



both documentation-related and on the shop floorLead/execute development projects aimed at deepening knowledge of production activitiesEnsure GMP documentation management, including archiving, data collection, and document destructionPrepare equipment cleaning samplesVerify the compliance of plasma receipt requirements

Requisiti fondamentali

Degree in scientific discipline or demonstrated/approved knowledge of manufacturing processesGood command of EnglishExcellent knowledge of the manufacturing process and quality principlesGood knowledge of cGMPGood ability to work independentlyGood communication and negotiation skillsProblem-solving attitudeGood teamwork skillsGood communication skillsProblem-solving attitudeLeadership skillsGxP/cGMP knowledgeCAPA managementDocumentation management

📌 Quality Operations Coordinator (Roma)
🏢 Takeda
📍 Roma