Specialist – Quality Operations

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 Specialist - Quality OperationsLocation - HyderabadAbout the Role 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 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 MBA Engineering equivalent from a reputed institute Min 3 years of experience in 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 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 Continuous Learning Dealing With Ambiguity Gmp Procedures Qa Quality Assurance Quality Control Qc Testing Quality Standards Self-Awareness Technological Expertise Technological Intelligence