Medical Device MS&T Specialist

MS&T Specialist (Medical Device)

Job Description Summary

#LI-Hybrid
Location: Hyderabad, India
Relocation Support: This role is based in Hyderabad, India. Novartis is unable to offer relocation support for candidates outside India: please only apply if accessible.

The role MS&T Specialist is 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.

Job Description

Major accountabilities:

• Support technology transfer, prepare & maintain Novartis medical device’s technical documents including Design History Files (DHF), Risk Assessment, Post-Market Surveillance (PMS) documents.

• Prepare & maintain Device Master Record (DMR), identify the gaps using manufacturing expertise, provide recommendations in compliance with the applicable standards (ISO, FDA, MDR, etc.,).

• Prepare and update post market surveillance (PMS) plan, related activities & report for medical devices.

• Collect, analyses and present data using appropriate visualization tool (e.g., Power BI) to support report preparation.

• Perform Data Administrator (DA) and Data Integrity (DI) check as per requirements.

• Initiate, manage and contribute to the Change Control process in management tools.

• Handling of SaMD activities. Maintaining documents related to SaMD (Distribution file, impact assessment of changes to SaMD distribution.). Collecting information related to regulatory compliances and co-ordinating with third-party manufacturer and business owner.

• Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed.

• Provide active support during internal and external audits by collecting and presenting the requested process/data and reports.

• Support implementing service quality and process improvement projects, CAPA management within global operations Centers.

• Ensure compliance with the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements.

Essential requirements:

• Scientific degree.

• Previous experience within the Medical Device/Pharmaceutical environment in a multinational organization.

• Data analysis/business intelligence expertise (e.g. Power BI, Excel, Minitab).

• Fluent in English.

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse team representative of the patients and communities we serve.

Accessibility and Accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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