High Salary) Global Statistics

Summary Provide leadership on the development and deployment of statistics strategy for the manufacturing network Provide excellence in statistical support to the platform sites and within the global network to drive the application of advanced and state-of-the-art statistical principles tools and methodologies to improve process understanding quality and compliance of the products efficiency and capability of the processes and profitability of the organization Interact with key stakeholder groups such as Operational Excellence to develop and deploy statistical applications Global Statistics PAT LeadLocation - HyderabadAbout the Role Provide leadership on the development and deployment of statistics strategy for the manufacturing network Provide excellence in statistical support to the platform sites and within the global network to drive the application of advanced and state-of-the-art statistical principles tools and methodologies to improve process understanding quality and compliance of the products efficiency and capability of the processes and profitability of the organization Interact with key stakeholder groups such as Operational Excellence to develop and deploy statistical applications Key Responsibilities Support definition of Internal Release Limits IRL and Out-of-Expectation OOE limits Develop best practices roadmap and harmonize application for NTO platform in alignment with corporate and regulatory guidelines Perform statistical analysis of process validation data for demonstrating validity and equivalence Plan and evaluate Design of Experiments DoEs in the frame of the Novartis Quality by Design QbD validation strategy Perform trending analysis in the frame of Ongoing Process Verification OPV Implement and apply Statistical Process Control principles e g control charts and other pattern recognition techniques Contribute to the development of fit-for-purpose platform to comply with long term OPV requirements Support the standardization and automated statistical evaluation of APQRs Support the introduction of Process Analytical Technology PAT by facilitating and enabling multivariate process monitoring and control principles e g by Multivariate Data Analysis MVDA Support development and deployment of new requirements such as definition of Internal Release Limits IRL in line with corporate and regulatory expectation Establish global platform procedures templates for statistical analysis Enable process improvement initiatives in alignment with OPEX organization and methodologies e g IQP Six Sigma Lean Manufacturing such as capability and stability assessments hypothesis testing MVDA computational Fluid Dynamics CFD multi linear curve fitting etc Deploy state of the art modelling and simulation techniques across the network to improve quality supply chain performance and profitability Define and implement strategy for PAT develop and validate MVDA models for on-line PAT methods support the design of an analytical robustness test perform statistical assessment of method validation data and technology and process transfer across sites Interact with internal and external Regulatory bodies and Health Authorities as well as internal functions as appropriate e g during inspections investigations etc in statistical aspects of data analysis and rationales Use statistical knowledge to analyze data to provide process understanding and to identify root causes of product and process failures provide technical expertise together with local statistical experts Essential Requirements Minimum 10 year experience of which min 2 year experience in manufacturing Proven process understanding Pharma GMP Regulatory aspects Proven experience of applied statistics is a must e g in the field of DoEs and multivariate data analysis Experience in the following software is a plus SAS R Minitab SIMCA-P Modde JMP SPSS Experience in deploying divisional strategy and leading in a matrix organization Desirable Requirements MSc in Statistic Mathematics natural science or Chemical Engineering Desirable PhD or equivalent experience Why Novartis Our purpose is to reimagine medicine to improve and extend peoples 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 https www novartis com about strategy people-and-cultureYoull receive You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook https www novartis com careers benefits-rewardsJoin our Novartis Network If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities join the Novartis Network here https talentnetwork novartis com network Skills Desired