Pilot Plant Quality Control Associate Expert
3 giorni fa
SummaryLocation: Ivrea, Italy #onsiteRole Purpose:This role utilizes chemistry laboratory skills to test and measure product or materials while ensuring that analysis is performed according to established Standard Operating Procedures (SOPs), Analytical Methods & current Compendia.About the RoleKey responsibilities:Executes analyses on excipients, raw materials, finished products, and packaging per internal SOPs and applicable pharmacopeias.Conducts stability studies, process and method validations, and activities related to tech transfer of pharmaceutical products.Performs instrument qualification and re-qualification (IQ/OQ/PQ) according to internal procedures.Records analytical data in compliance with ALCOA+ principles and data integrity requirements.Reviews GMP documentation, batch records, analytical reports, and certificates for completeness and compliance.Collaborates with QA, Production, and R&D; supports method transfers, troubleshooting, and safe lab/5S practices.Participates in audits and inspections by providing data and responses; contributes to CAPA, deviations, change control, and SOP updates.Tracks KPIs: on-time completion and right-first-time rates, data integrity compliance, audit outcomes, documentation quality, and continuous improvement impact.Essential Requirements:Degree in ChemistrySolid technical-scientific knowledge of pharmaceutical/chemical QC or equivalent analysisPrevious experience working in a laboratory environment in the pharmaceutical industryExperience in GMP environmentFluent in Italian and EnglishWhy Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: DivisionDevelopmentBusiness UnitDevelopmentLocationItalySiteIvreaCompany / Legal EntityIT58 (FCRS = IT058) Advanced Accelerator Applications Italy SrlFunctional AreaResearch & DevelopmentJob TypeFull timeEmployment TypeRegolareShift WorkNo
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