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Major Accountabilities Supervise the general conditions of hygiene of the premises subject to its managementContribute in assuring the validation/qualification status of the production site, equipment, training of personnel and management of quality documentationResponsible for the provisional release for the shipment of batchesWork in shift with other QA officers to oversight the production and quality control activities.Archiving and support in managing the site GMP documentation, review of batch records and assure the timely closure of the manufactured batches.Contribute in maintaining the local quality system as per GMPs and corporate guidelines and in assuring the respect of the GMPs and Health Authorities requirements at local levelSupport the QP in the preparation of batches release documentsCollaborate in redaction of site GMP documentation and preparation and printing of batch documentationSupport during the external audits by the authorities and corporate auditsCollaboration in data compilation of Product Reviews, oversight on investigations and monitoring of resulting actions are checked and approved.Participate to the self-inspections as per approved annual plan and to the external auditsBe responsible for the appropriate level of quality oversight during the GMP activities of the facility verifying they are executed according to the applicable standards in manufacturing, quality control, distribution and quality processes.Minimum Requirements Education: Scientific degree in Pharmacy, Chemistry or Biology1+ years of experience in a Quality department.Strong affinity with and awareness of Quality issuesGood organizational skills including attention to detailsSolid knowledge of quality system (GMP) and basic knowledge of regulatory requirementsFluent English verbally and in writingWhy Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us Learn more here: and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: 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.#J-18808-Ljbffr
