Specialist- MS&T

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