Summary
Overview
Work History
Education
Skills
Websites
Accomplishments
Software
Certification
Timeline
Generic
Purba Saha

Purba Saha

NPI/LCM officer
Aurangabad

Summary

NPI/LCM officer with a demonstrated history of working in the medical device industry, at Johnson & Johnson. Collaborative team player with cross-functional skill in research and manufacturing processes. Dedicated to ensuring compliance with regulatory standards while delivering solutions that improve voice of customer and enhance healthcare delivery. Strong attention to problem-solving abilities to drive success in designing safe, effective, and high-quality medical devices.

Overview

2
2
years of professional experience
4
4
Certifications

Work History

Corporate Communication

Dice
04.2022 - 10.2022

Management of all corporate spending, end-to-end visibility from expense claims and reporting to compliance & reimbursements with Dice.

  • External Communication: Managed the organization's external communication channels to build, engage and retain relationships with stakeholders such as customers, investors, media, end users. This includes crafting press releases, coordinating summit Fintech events, and managing the organization's image through engaging technical and Fintech news/updates. With relevant content across all platforms, team had achieved in attracting 15% outbound clients with relevant content and engagement.
  • Evaluation and Analysis: Monitoring and analyzing communication/ marketing efforts to assess their effectiveness and impact on converting potential clients to onboarded customers. This included tracking media coverage of various campaign conducted and gathering feedback from stakeholders to continuously improve communication strategies.
  • Competitive Analysis: Monitoring data also provided valuable insights into the strategies of other spend management competitors. Periodic tracking of parameters such as social media engagement, e-mail campaign open rates, website traffic, and keyword rankings, I, as an marketer benchmarked performance against competitors in terms of their social media engagement and identify areas within organization to gain a competitive advantage.
  • Key skills applied: Written and verbal communication, technical writing, comparative analysis, market research.

NPI/LCM Officer

Johnson & Johnson- Ethicon
10.2022 - Current
  • Ethicon, subsidiary of J&J, with expertise at manufacturing of suture and other wound closure healing medical devices.
  • NPI/LCM officer: -
  • Performed following activities in each project.
  • · Futuramic I: -
  • This is a design change project that replaced Single Barrier folder type in identified product codes with Zipper III Tray-lid folder type for various cost and resource effective factors.
  • - Oversaw end to end implementation of the change project from issuance of validation batches to DHF closure.
  • - Supported design validation and ensured closure of design change notice (DCN) for implementation of design output requirements.
  • - Evaluated all process validation assessment, protocols, reports and maintained records in PLM software (Adaptiv) in accordance with site/franchise procedure and MDR 2017.
  • - Product Drawings and packaging material specification updated as per design change.
  • - Promote collaboration and support among CFT members during the validation activities and overall governance of project.
  • - Undertook nonconformances that arose during validation activity and made sure investigation was performed as per nonconformance process flow of the site.
  • - Documentation of regulatory documents for CDSCO submission.
  • · Norderstedt Vicryl Pus conversion: -
  • - The change project is to change suppliers of raw material that are incoming from franchise site at Cornelia with raw material provided by Franchise site at Norderstedt.
  • - Performed comparative analysis between the raw material specification, test methods, manufacturing process, construction of both sites to come to conclusion of classifying project under major or minor change as per regulatory requirements.
  • · Stake Swage Press Machine: -
  • - 06 SSP machines were validated at site for enhancement in swaging process of suture.
  • - Design validation: Responsible for evaluation of conformance of design input as per ISO 13485:2016.
  • - Conducted design change notice meeting of the project to ensure DHF closure of the project.
  • Thunderbird: -
  • - Performed User Acceptance Test to integrate a new artwork management software in a new machine.
  • - Supported creation of protocol for UAT to pass the requirements of Quality Management system.
  • · Extra activities: -
  • - Overtook nonconformances of the department and participated in investigation and failure mode analysis.
  • - Maintained and reviewed Device Master File (DMF) annually as per regulatory requirements.
  • - Filled interim position of Business Excellence role at site for 5 months.
  • - Ensured adherence of CIP targets at site.
  • - OEE governance of major 6 machines at site and development of process to record output data from machine in terms of availability and performance of machine and quality of the manufactured products.
  • - Underwent JJPS (Johnson & Johnson Production system) for continuous process improvement.
  • - Maintained monthly scorecard of site summarizing on metrics like Compliance, EH&S, Supply chain and strategic projects.

Education

Electronics and Telecommunication -

Symbiosis Institute Of Technology

Skills

Data Visualisation

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Accomplishments

- Final year paper titled"FPGA Based Implementation of Neural Network" published in IEEE Xplore as a part of 2022 International Conference on Advances in Computing, Communication and Applied Informatics (ACCAI).


Software

Power BI

Adaptiv

Microsoft Office

MATLAB

Certification

Flawless project execution

Timeline

NPI/LCM Officer

Johnson & Johnson- Ethicon
10.2022 - Current

Corporate Communication

Dice
04.2022 - 10.2022

Electronics and Telecommunication -

Symbiosis Institute Of Technology
Purba SahaNPI/LCM officer