Location: Ivrea, ItalyRole Purpose:Provide front line technical and scientific expert support for all process-specific topics to ensure execution of processes on-time (business continuity); in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g.HSE) and to allow continuously improving in quality, productivity efficiency.
About the RoleOperational activities
Provide front line expert support for all process-specific topics to productionDuring build up Phase, review/supervision/management of activities related to the qualification of the facilities, utilities and manufacturing lines.Coordinate and ensure the completion of all production operations on time, in accordance with the documentation and in compliance with GMP, SSE and 5S rulesEnsure real time shop floor support as an expert on technical problems and ensuring that appropriate immediate corrective/remediation actions are implementedPerform real time batches follow-up and batch records technical reviewEnsure that all production documents are systematically up to date and that the production documents necessary for the validation / revalidation of processes are availableCompliance activities
Ensure timely treatment of deviations, complaints, OOE, OOS, and the implementation of effective CAPAs within agreed timelinesLead thorough Root Cause Investigation process using investigation tools and methodologyCollaborate with Engineering and Validation experts in the context of process deviationsEnsure that all process changes in assigned products are managed through appropriate change control procedureCollaborate with Engineering and Validation Experts regarding the definition of the validation strategyParticipate in continuous improvement and productivity projectsProvide support to teams for the implementation of improvements, actions 5S, the exploitation of production data and the implementation of controls chartsActively participate in the development of production staff in the continuous improvement process. Provide operational support to teams during technology transfersQuality and HSE
Promote and improve the Quality culture in collaboration with Quality Assurance.Participate to, in collaboration with Quality Assurance, the upgrading, and the improvement of Quality by initiating, organizing and checking the practical application on the shop floorEnsure overall inspection readiness for area of responsibilityBe responsible for the compliance to the principles and practices described in the "Novartis Manufacturing Manual" and their implementation on the site for his areaWhy Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
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