380525BR Job ID: 380525BR Job Description: Specialist MS&T Location – Hyderabad #LI Hybrid About the Role: Responsible for managing medical device service aspects focused to ensure accurate and timely preparation and maintenance of medical device technical documents, in accordance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements, the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures and agreed between GOC and business partners. Key Responsibilities: • Oversees the distribution life cycle; technical, regulatory, and organizational aspects required to distribute the TP-SaMD. • Supports the establishment and maintenance of the distribution file and compliance to MDR. • Manage the operation of the distribution package and communication / forwarding of information to the third-party manufacturer if required. • Perform gap assessment w.r.t. the changes to TP-SaMD or distribution regions. • Coordinate with multiple stakeholders including Medical Devices QA, Medical Devices RA, Novartis Country Quality Representatives and supplier (like Ada Health, etc.) • Support technology transfer, prepare & maintain Novartis medical device’s technical documents including Design History Files (DHF), Risk Assessment, Post-Market Surveillance (PMS), Human Factors Engineering (HFE) /usability engineering documents. • Prepare & maintain Device Master Record (DMR), identify the gaps using manufacturing expertise, provide recommendations in compliance with the applicable standards (ISO, FDA, MDD/MDR, etc.,). Position Title: Specialist MS&T Minimum requirements: Essential Requirements: • Pharmacy/ Science/ MBA / Engineering/ equivalent from a reputed institute • Min 3 years of experience in MS&T, medical devices, Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug products • Experience in SaMD (Software as Medical Devices) MDR is desirable • Knowledge on MDR, CSV experience, Design Control & Documentation Management & Drafting QAA ( TQW & CoreDox ) and Good Documentation practices. • GxP knowledge, Basic IT knowledge Desirable Requirements: • Fluent in English (written and spoken) • 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 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. Job Type: Full Time Country: India Work Location: Hyderabad, AP Functional Area: Technical Operations Division: Operations Business Unit: GLOBAL MANUFACTURING FUNCTIONS Employment Type: Regular Company/Legal Entity: Nov Hltcr Shared Services Ind 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. Shift Work: No Early Talent: No
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