Process Support Unit Lead
2 settimane fa
SummaryThe Process Support Unit Lead leads the process unit team in coordinating and planning of all activities with end-to-end manufacturing responsibility (logistics, project work, operational excellence, resources and budget/costs) in a way that is consistent with a culture of self-direction (empowerment andaccountability).Ensures full compliance with quality, Health, Safety and Environment (HSE), Good Manufacturing Practices (GMP), customer service, statutory, regulatory and Novartis requirements.About the RoleMajor accountabilities:Transmits knowledge, skills and information to members of his team on objectives, problems, performance indicators, values and behaviorMonitor compliance activities necessary for the release of batches produced incompliance with the defined dates.Ensure that the processes remain consistent with good manufacturing practices (cGMP) and apply the rules and regulations for safety, health and the environment.Ensure the appropriate management of the quality events within the appropriatetimeframe (escalation, description, investigation of the cause, evaluation of the impact and criticality, etc.).Ensure the availability of appropriate operational expertise resources in order tomaintain the validated state of the manufacturing processes in the unit as well as the qualified and validated state of the equipment in the area.Provide necessary support for the preparation and submission of regulatory dossier (in the context of transferring new products or variations of existing products / processes), and in answering questions from health and safety / environment authorities.Manage the preparation, execution and follow-up of internal and external audits and GMP and HSE inspections.Manage the production documentation flow within the production unit (SOPs; MBRs; Forms etc).Ensure overall inspection readiness for area of responsibility.Participate to the definition of the operational improvement strategy and the portfolio of continuous improvement projects.Plays a key role in the prioritization of improvement actions based on available resources.Essential requirements:Scientific or Engineering degree.Previous solid experience within the manufacturing/QA/engineering department of a pharmaceutical company.People management skills.Proficient in Italian.Fluent in 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.Combining to achieve breakthroughs that change patients' lives.Ready to create a brighter future together?Join our Novartis Network: Not the right Novartis role for you?Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally:DivisionOperationsBusiness UnitProduction / ManufacturingLocationItalySiteTorre AnnunziataCompany / Legal EntityIT08 (FCRS = IT008) Novartis Farma S.p.A.Functional AreaTechnical OperationsJob TypeFull timeEmployment TypeRegularShift WorkNoNovartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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Process Support Unit Lead
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Torre Annunziata, Campania, Italia Novartis A tempo pieno 60.000 € - 120.000 € all'anoSummaryThe Process Support Unit Lead leads the process unit team in coordinating and planning of all activities with end-to-end manufacturing responsibility (logistics, project work, operational excellence, resources and budget/costs) in a way that is consistent with a culture of self-direction (empowerment andaccountability).Ensures full compliance with...
