Summary
About the Role
Major Accountabilities
Medical Devices Support:
- 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.,).
- 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. Tableau, Qlik Sense) to support report preparation.
- Perform Data Administrator (DA) and Data Integrity (DI) check as per Subway workflow requirement.
- Initiate, manage and contributes to the change control process in Agile PLM / TrackWise.
- Perform a role of originator / owner / approver in exception handling systems like AQWA Q/ TrackWise / 1QEM, Condor.
- Comply with internal functional requirements such as KPI reporting, ticket management tools and any other internal procedures and processes
- Assist the department on any other ad hoc activities/ requests to meet the business requirements
- Regularly communicate with partners and obtain feedback on services delivered
- Focus on timely completion of all relevant and assigned trainings
- Comply with accuracy and timeliness of deliverables
- Comply to the applicable Novartis operating procedures as per legal/ IT/ P&O 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
- Adherence to the current GxP and compliance policies of Novartis Perform and deliver MS&T services in support of product quality compliance and regulatory workflows
- Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY etc.) to ensure appropriate execution of service deliverables
- Generate and analyze predefined and ad-hoc reports in various applications (such as AGILE PLM, AQWA, 1QEM etc.) and perform follow-up actions if required
- Escalate service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures
- Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements
- Support implementing service quality and process improvement projects, CAPA management within global operations Centers
Key Performance Indicators (Indicate how performance for this role will be measured)
- Quality / Accuracy / Right First Time
- Timeliness
- Deviations / Escalations
Job Dimensions (Indicate key facts and figures)
Number of associates reporting: NA
Direct: NA
Financial responsibility: NA
Indirect: NA
Ideal Background / Requirements for the role
- 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
- GxP knowledge, Basic IT knowledge
- Fluent in English (written and spoken)
- Good communication, presentation and interpersonal skills
- Experience of working closely with the global stakeholders
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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