Specialist - MS&T (Medical Devices) job opportunity at Novartis.

Home Jobs In India Tag: Job Specialist - MS&T (Medical Devices) position at Novartis


DatePosted 2 Days Ago bot
Novartis Specialist - MS&T (Medical Devices)
Experience: 6-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeAssociate
loacation Hyderabad (Office), India
loacation Hyderabad (Off..........India

Job Description Summary Location – Hyderabad #LI Hybrid About the Role: The purpose of the role is to be 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 MS&T NOCC and business partners within Operations network.   Job Description Key Responsibilities: Technical documentation management (DHF, DMR, PMS) Risk assessment and gap analysis Technology transfer support Data analysis & visualization (Power BI) Data Integrity (DI) & Data Administrator (DA) checks Change Control management SaMD documentation & coordination with third-party manufacturers Creation/review of GxP documents (SOPs, reports, investigations) Audit support (internal & external) CAPA support and process improvement activities Compliance with ISO, FDA, MDR, and Novartis quality standards Essential Requirements High quality output / accuracy / Right First Time Timely delivery of tasks Ability to manage deviations and escalate when needed Desirable Requirements Experience with SaMD documentation Coordination with third‑party manufacturers Exposure to global operations Additional quality or regulatory certifications (implied) Education Degree in Pharmacy, Science, Engineering, MBA, or equivalent from a reputed institute Experience Minimum 6 years in MS&T, medical devices, Quality Assurance, Regulatory, or pharmaceutical manufacturing Strong GxP and cGMP knowledge Broad IT knowledge; proficient in MS Office Experience working with global stakeholders Excellent communication, presentation & analytical skills Project management experience 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 Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. 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.   Skills Desired Change Control, Continual Improvement Process, Data Analytics and Digital, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process, Manufacturing Production, Operational Excellence, Process and Cleaning Validation, Process Control, Quality Control, Regulatory Compliance, Resilience and Risk Management

Other Ai Matches

AD, Cell Therapy Operations Manager - New York / Tri-State Applicants are expected to have a solid experience in handling Cell Therapy Operations Manager - New York / Tri-State related tasks
Supply Chain Dispatch & Shipping Expert Applicants are expected to have a solid experience in handling Job related tasks
Kierownik ds. Kluczowych Klientów | Kardiologia | Województwo Lubelskie Applicants are expected to have a solid experience in handling Job related tasks
Specialist kontrole kakovosti (m/ž/d) Applicants are expected to have a solid experience in handling Job related tasks
Director, Data & Analytics Enablement Applicants are expected to have a solid experience in handling Data & Analytics Enablement related tasks
Senior Manager, Public Affairs Applicants are expected to have a solid experience in handling Public Affairs related tasks
AD, Engineering (Design & Construction) Applicants are expected to have a solid experience in handling Engineering (Design & Construction) related tasks
Site Quality Head, Texas (AD level) Applicants are expected to have a solid experience in handling Texas (AD level) related tasks
Assoc. Director SAP Cloud Platform Integration Applicants are expected to have a solid experience in handling Job related tasks
Associate Director Biomedical Research Clinical Quality Applicants are expected to have a solid experience in handling Job related tasks
Senior Specialist, Automation Engineer Applicants are expected to have a solid experience in handling Automation Engineer related tasks
Intern - Finance Applicants are expected to have a solid experience in handling Job related tasks
IT Sr. Business Analyst Customer Engagement Applicants are expected to have a solid experience in handling Job related tasks
Manager MS&T (Validation expert) Applicants are expected to have a solid experience in handling Job related tasks
Strategy Manager Applicants are expected to have a solid experience in handling Job related tasks
Manufacturing Experts Applicants are expected to have a solid experience in handling Job related tasks
Associate Director Biostatistics Applicants are expected to have a solid experience in handling Job related tasks
Global Monitoring Functional Excellence Lead Applicants are expected to have a solid experience in handling Job related tasks
Radioligand Therapies (RLT) Associate Director, Priority Accounts - Chicago Applicants are expected to have a solid experience in handling Priority Accounts - Chicago related tasks
Manager - Project Management Web Experience Applicants are expected to have a solid experience in handling Job related tasks
Payroll Services Senior Expert Applicants are expected to have a solid experience in handling Job related tasks
Shift Supervisor, Weekend Days Applicants are expected to have a solid experience in handling Weekend Days related tasks
Skrbnik osnovnih podatkov materialov (m/ž/d) / Site Master Data Expert (m/f/d) Applicants are expected to have a solid experience in handling Job related tasks