Job
Description
Summary Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners. Manage Quality aspects & projects within area of responsibility. Support manufacturing sites with QC and related activities. About The Role Key Responsibilities: Coordination and management of analytical method transfers and stability studies. Compilation of data reports Life-cycle management of analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements. Handling of deviations, investigation, OOS/OOE/OOT cases as well as changes and complaints Perform statistical data analysis to report Out of Expectations (OOE), out of trends (OOT), etc SAP master data management: Maintenance of master data, creation of Q-info records and other SAP related activities. Validate spreadsheets Collect, transcribe and/or compile data from various repositories (SAP, LIMS, external COAs) Author, approve and archive Impurity risk assessments – Nitrosamines, residual solvents, etc Trend and report all QMS elements as per the request Monitor, trend and report Health Safety and Environmental parameters Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents (Common Technical Document modules)). Perform activities of a Quality Control expert as defined by the respective sites Support regulatory requirements – routine queries, Chromatogram requests Compile Quality performance management decks Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed Essential Requirements Pharmacy/ Science/ equivalent from a reputed institute Min 3 years of experience in Quality Control / Analytical R&D / Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices GxP knowledge, Basic IT knowledge Good communication, presentation and interpersonal skills Experience of working closely with the global stakeholders Why 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: https://www.novartis.com/about/strategy/people-and-culture You’ll 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-rewards Commitment 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. Join 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. 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? https://www.novartis.com/about/strategy/people-and-culture 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: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Show more Show less
