Pilot Plant Quality Control Associate Expert

2 settimane fa


Ivrea, Italia Novartis A tempo pieno

**Summary**: 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 Role**: **Key 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 Chemistry - Solid technical-scientific knowledge of pharmaceutical/chemical QC or equivalent analysis - Previous experience working in a laboratory environment in the pharmaceutical industry - Experience in GMP environment - Fluent in Italian and English **You will receive**: You can find everything you need to know about our benefits and rewards in the Novartis Life **Commitment to Diversity and Inclusion**: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Division Development Business Unit Innovative Medicines Location Italy Site Ivrea Company / Legal Entity IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl Functional Area Research & Development Job Type Full time Employment Type Regolare Shift Work No



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