Job Description
Quality specialist - level 4 - Z7, 12 monthsJob Profile SummaryLead smaller and less complex projects, while supporting complex initiatives under guidance. Execute higher-complexity routine tasks, including deviation investigations and change controls. Manage projects and processes in line with agreed timelines to support departmental objectives. Ensure compliance with cGMP within TRD.Job DescriptionMajor Accountabilities:Provide support and/or deliver services within the designated area of responsibilities, either independently or as part of the team. Provide functional expertise to TRD line functions and other QA units as neededAuthor, review, and approve GMP-relevant deliverables to ensure compliance with cGMP & project related quality requirements.Manage project-related activities to establish or enhance processes, develop tools, and implement quality-related initiatives.Contribute to projects as an active project team member.Provide GMP-related support to TRD line functions within the designated area of responsibility.Ensure compliance with internal and external quality and safety requirements (e.g., Quality Manual, cGMP, health authority guidance, Novartis procedures).Support and drive the implementation of Novartis QMS within TRD. Key Performance Indicators:In accordance with departmental objectives such as support of projects/processes with agreed quality and delivery dates, passing of internal and external inspections.Maintain sound working relationships with partners and customers.Meet quality and timelines in area of responsibility.Feedback from team members, stakeholders and managers.Act in accordance with Novartis standards in particular; cGMP, ethical, health, safety and environment (HSE), and information security (ISEC)The number and severity of issues identified during inspections and internal audits.Role model Novartis culture, values & behaviors.Work Experience:Quality compliance & Quality Management Systems (GxP; strong GMP focus)Deviation ManagementChange Control ManagementSOP (Standard Operation Procedure) ManagementDrug development / R&D exposure (preferred)Skills:Business PartneringOperational ExcellenceCollaborationRegulatory requirements knowledgeDealing with ambiguityProblem Solving SkillsLeadershipCommunication skillsData IntegrityDigital savviness Languages:English.Education (minimum/desirable): MastersBachelor/Technician (> 5 years in pharma industry)
