Location: Ivrea, Italy #onsiteRole PurposeSupport the pilot plant ramp up and operationalization process through the creation of a compliant manufacturing and QC‐related quality system which comprises master batch records, logbooks, forms, and procedures. Support qualification and validation activities by managing and reviewing the related documentation. Ensure the compliance of all business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, in preparation for external and corporate audits and Health Authority inspections. Maintain site compliance through third‐party management, trainings, change controls, self‐inspections, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators) monitoring.Major AccountabilitiesSupport site qualification and validation activities (advising, review, approval)Implementation of quality systems, including documentation managementSupplier management activities (agreements, oversight, audit)Preparation, support and coordination of CAPA follow‐upAudit and inspection preparation and support, ensuring applications and certificate maintenance to local HAChange control review and approvalEnsure local DI and eCompliance oversight (training, inspections, plan, risk ID, etc.)KPI/KQI trendingHandling of technical complaints, deviations, and quality events related to Novartis products, systems or processesKey Performance IndicatorsSuccessful support of projects with agreed quality and delivery dates, passing internal and external inspectionsMeet quality and timelines for all projectsAct in accordance with Novartis standardsNumber and severity of cGMP issues identified during internal and external auditsYear‐end figures within budget; successful coordination of departmental operational activitiesWork ExperienceChange control managementAudit and inspection managementCompliance risk managementGood Manufacturing Practices (cGMP)GxP experienceKPI reportingQuality management systemPrerequisitesMinimum of five years in the pharmaceutical industry (sterile preferred)Previous experience in Health Authority inspection support (back‐room / SME)Experience with QMS document managementFluency in EnglishExperience working with electronic quality systems (e.g., change controls, deviations, OOX, complaints, etc.)Strong quality mindset, documentation, communication, and cross‐functional collaboration skillsLanguagesItalianEnglishNovartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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