Job Description

Senior QA Expert, ESO Large Molecules Location - Hyderabad Hybrid About the Role: The position ensures all aspects of manufacturing, testing, release and distribution for key biologics and/or sterile pharmaceutical products at strategic external supplier sites comply with international standards of current Good Manufacturing Practice (cGMP), regulatory requirements, the Novartis Group Quality Manual, and the applicable Quality Agreements. Key Responsibilities: Provide Leadership & manage Quality Assurance Managers in all quality related matters and to ensure that all aspects of the operational business comply with cGMP (Current Good manufacturing Practices) legal and regulatory requirements and the Novartis Quality Manual & Policies. Ensure that all products manufactured by site/External Supplier in addition to the imported products for local site are released to the market according to Novartis Quality Standards. Oversight of Quality Operations across site. Inbound QA Oversight. Outbound QA Oversight. MBR review and approval. Product release. QA for Quality Control and AS and T. QA Operational Excellence. Initiate and drive local hiring process. Line responsibility and daily walkthrough. Lead OpEx Projects. Investigation of Deviation, OOx, Complaints. Define and implement CAPAs. Support transfer Projects & validation studies. Track team metrics and ensure KQI /KPI meet requirements. Review and approve text and design. HSE incidents reporting and action follow up. New equipment commissioning Support (OQ, PQ). Define improvement areas in process and products. Resource and capacity (people and equipment) planning and workload management. Performance and leadership Support to specialist team. Ensure availability of equipment, chemicals and consumables, AS appropriate. SOP review and revision. Perform local training and monitor training status. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt. Distribution of marketing samples (where applicable) Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Minimum Requirements Essential Requirements: Preferred Qualification- M. Pharma with minimum 10 years of experience in Manufacturing Quality/Compliance. Experience in Large molecules handling/Aseptic processing is preferred. 10 years of experience in in the pharmaceutical industry. Min 8 years of experience in the manufacturing of sterile pharmaceuticals. Expert knowledge in aseptic/sterile pharmaceutical processes and manufacturing of biologics. Min 10 years of experience in operational quality assurance. Expert knowledge of cGMP requirements for major regulated markets (EU, US). Advanced experience with FDA, EMEA and other Health Authorities. Expert in risk management. Advanced understanding of project management. Expert in communication and advanced negations skills. Advanced decision-making skills.. 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 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. Division Operations Business Unit QUALITY Country India Work Location Hyderabad, AP Company/Legal Entity Nov Hltcr Shared Services Ind Functional Area Quality Job Type Full Time Employment Type Regular Shift Work No Early Talent No

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