Analyst - Quality Operations

5 days ago

Hyderabad, Telangana, India Novartis Full time

Summary -Manages Quality aspects and projects within area of responsibility -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems Major accountabilities 1 Handling of Audit CAPA actions Deviations and Investigations 2 Preparation of annual audit plans3 Monitoring and maintain of KQI s and KPI s 2 4 Maintenace of Shrepoints and Repositories xc2 xb75 Responsible to update the information on SharePoint trackers review the applicable documents for correctness and archival of necessary documents on SharePoint xc2 xb76 Provide Administrative support in preparation of Quality Management Review meeting slide deck metrics reporting xc2 xb77 Preparation approval and management of QAA s 8 Develop and maintain process SOPs working procedures and process maps xc2 xb79 Provide support for GMP External Audits and inspection management activities HA and Self Inspection Audits 10 Maintain Approved supplier list for GxP vendors 11 Preparation of UQAP Unified Quality Audit Program Audit preparation support and QARP Quality assurance responsible Person Role for audit CAPA Management Minimum Requirements M Pharm equivalent from a reputed institute Min 4-6 yr Experience in Quality Assurance Regulatory or in the manufacturing of pharmaceutical drug substances or products Medical device Basic awareness of GxP compliance requirements Work Experience QMS Knowledge w r t deviations Investigations handling of CAPA 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 Continued Learning Dealing With Ambiguity Gmp Procedures Qa Quality Assurance Quality Control Qc Testing Quality Standards Self-Awareness Technological Expertise Technological Intelligence

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