Specialist - MS&T (Medical Devices)
BLS 2024 data (national)
Description
Job Description Summary
Location – Hyderabad #LI HybridAbout 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 ManagementSimilar Jobs
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PHARMACEUTICAL
Small Molecules, Vaccines, Biologics / Diagnostics