SummaryThe QC Supervisor supports the QC Head to ensure that Quality Control processes for materials acceptance, batch quality control, and QC equipment validation/qualification are executed in full compliance with cGMP regulations, as well as corporate and national guidelines.About the RoleMajor accountabilities:Be the Deputy of QC Head in managing, coordinating, and approving the execution of analytical activities for batch release and acceptance of raw materials and packaging materials according to specifications.Ensure proper availability, storage, identification, labeling, recording, and monitoring of QC materials, reagents, and standards according to SOPs and specifications. Ensure correct storage of Reference and Retention Samples of raw materials and products.In case of analytical results out of specification (OOS), out of trend (OOT), out of expectation (OOE), or System Suitability Test failures, collaborate with QC Head to perform investigations and verify the implementation of related CAPAs. Ensure all methods used in QC analysis are validated according to SOPs, MA, and cGMPs. Support the QC Head in reviewing and redacting SOPs, protocols, and reports.Collaborate with QC Head on stability programs and the annual product review; ensure timely execution of stability analyses.Assist QC Head in the initial and periodic training of QC analysts. Manage the presence, shifts, and performance of QC Technicians when QC Head is not on site.Maintain, review, and approve records of QC activities (logbooks, forms, analytical batch records).Support QC Head in periodic self-inspections and external audits (Health Authorities, Certified Bodies, Suppliers). Contribute to maintaining the local quality system in compliance with GMPs and corporate guidelines, ensuring adherence to GMPs and health authority requirements at the local level.Guarantee cleanliness, tidiness, and adherence to Good Laboratory Practice.Ensure high standards in handling radioactive materials within the area of responsibility, operating in full compliance with HSE guidelines.Support the development and implementation of projects related to new or existing products.Essential requirements:Scientific Degree (CTF, Pharmacy, or Chemistry preferred).Previous experience in a similar role within a GMP laboratory environment.Available to work in shifts, including night shifts.Fluent in Italian; good knowledge of English.Why 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 to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? Learn moreJoin our Novartis Network: Not the right role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as they arise: https://talentnetwork.novartis.com/networkCommitment to Diversity and Inclusion: Novartis is dedicated to building an inclusive work environment and diverse teams that reflect the patients and communities we serve.Benefits and Rewards: Read our handbook to learn about all the ways we'll support your personal and professional growth: https://www.novartis.com/careers/benefits-rewards
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