Job Description Summary
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:
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.
Assist the department to any other ad hoc activities/ requests to meet the business requirements
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:
· Quality / Accuracy / Right First Time
· Timeliness
· Deviations / Escalations
Specific Professional Competencies
· Good Documentation Practices
· Risk Analysis
· Post-market Surveillance
· Technical Documentation maintenance for medical devices
· Gap assessment
· Technology Transfer
· Report writing
· Data Analytics
· Change Control Management
· Project Management Skills
Desirable Requirements:
Subordinate Functions:
N/A
Number of Associates:
Direct: N/A
Indirect: N/A
Financial responsibility (where appropriate):
N/A
Impact on the organization (where appropriate):
N/A
Ideal Background:
Education:
Pharmacy/ Science/ MBA / Engineering/ equivalent from a reputed institute
Languages:
Fluent in English (written and spoken)
Experiences:
Min 6 years of experience in MS&T, medical devices, Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug products
GxP knowledge, Broad IT knowledge and Proficient in MS-Office
Excellent communication, presentation, interpersonal and analytical skills
Experience of working closely with the global stakeholders
Project Management 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
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