Ph3Summary /h3 pLocation: Ivrea, Italy #onsite /p h3Role Purpose /h3 pSupport the pilot plant ramp up and operationalization process through the creation compliant manufacturing and QC‑related quality system which comprises master batch records, logbooks, forms, procedures. Support qualification and validation activities managing and reviewing the related documentation. /p pEnsure the compliance of all the business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, in preparation of external and corporate audits and Health Authority inspections. /p pMaintain the site compliance through 3rd party management, trainings, change controls, self‑inspections, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators) monitoring. /p h3About The Role /h3 h3Major Accountabilities /h3 ul liSupport site qualification and validation activities (advising, review, approval). /li liImplementation of Quality Systems (incl. documentation management). /li liSupplier management activities (agreements, oversight, audit). /li liPreparation/support and coordination of CAPA/follow‑up. /li liAudit and inspection preparation and support, ensure applications, certificate maintenance etc. to local HA. /li liChange control review/approval. /li liEnsure local DI and eCompliance oversight (training, inspections, plan, risk ID etc). /li liKPI/KQI trending. /li liHandling of technical complaints, deviations, quality events related to Novartis products, systems or processes. /li /ul h3Key Performance Indicators /h3 ul liSuccessful support of projects with agreed quality and delivery dates, passing of internal external inspections. /li liMeet quality timelines for all projects. /li liAct in accordance with Novartis standards. /li liThe number and severity of cGMP issues identified during internal and external audits. /li liYear‑end figures within budget; Successful coordination of departmental operational activities. /li /ul h3Work Experience /h3 ul liChange Control Management /li liAudit Inspection Management /li liCompliance Risk Management /li liGood Manufacturing Practices (cGMP) /li liGxP Experience /li liKPI ReportingQuality Management System /li /ul h3Prerequisites /h3 ul liMinimum of 5 years in pharmaceutical industry (sterile preferred). /li liPrevious experience in HAs inspection support (backroom / SME). /li liExperienced in QMS document management. /li liFluency in English. /li liExperience working with electronic quality systems (e.g. change controls, deviations, OOX, complaints, etc.). /li liStrong quality mindset, documentation, communication, and cross‑functional collaboration skills. /li /ul h3Languages /h3 ul liItalian /li liEnglish /li /ul h3Commitment to Diversity and Inclusion /h3 pNovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. /p /p #J-18808-Ljbffr