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: You ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Commitment to Diversity and Inclusion: . Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:
