Tamal Ghosh

Experience

• 

  Tata Consultancy Services

  Oct 2013 - now

  Scope : Manufacturing Site transfer to enable financial goal and enhance manufacturing Capacity.Responsibility :• Develop critical documentations to support As-Is transfer• Stability, Transit test Protocol development• Review and Approve Manufacturing Validation Report - OQ, PQ• Writing Protocols, Engineering Studies, and Completion Reports (IQ, OQ and PQ)• Project Management activities to meet project schedule• Liaison between sending and receiving site team• Change management- Change Order Ownership Show less Scope QMS Gap assessment and Remediation for SaMD Product Responsibility: • Managing team on the remediation of Quality Management System of medical device Company.• Identified gaps in existing documents as per standard ISO 13485: 2016, ISO 14971: 2019, ISO 14971:2019, IEC62304, IEC62366 and regulation like US FDA, EU MDR, UK MHRA, CMDR, TGR Australia, Japan MHLW, CFDA, Korea KFDA, Brazil ANVIZA, MEDSAFE New Zealand and Taiwan regulatory requirements. • Remediate or created regulatory documents such as (Quality Manual, Policy Documents, Procedure- Complaint Handling, Adverse Event Reporting, Field Action/Recall, Post-market surveillance, Clinical Evaluation, Risk management, international product Registration, Preparing and Filing 510 (K), Purchasing Control, Etc. Form/Template-) where gap identified as per standard.• Reviewed the documents wherever is required.• Project Planning, Resource Planning, Technical Monitoring, Training and Development Show less Scope: Sustainable Cost improvement achieving through Business Transformation OpportunitiesResponsibility: • Develop the Project Plan• Work in Supplier Identification, Product Drawing Update or create newly from scratch, Created Engineering Specification document, Reverse Engineering, Developed IOVV (Input, Output, Verification and Validation) with the help of User Need and Design Input, Hazard Analysis, FMEA, Test Plan Creation, Test Report Preparation, BoM Creation or modification in PLM system and Drawing, FAI Analysis, IQ, OQ, PQ and Release all the tech package through Change Order.• Complaint handling process as a part of Post market Surveillance. Any complaints received on a product (Implants/Instruments) is evaluated and investigated to find out the root cause• Prepare Changer Order and release those in PLM with associated documentation.• Supervised team members and reviewing all the work and delivered defect free work within timeline.• Project Management (Planning, Resource Planning, Technical Monitoring and Talent and development) Show less

  • Design Engineer

    Oct 2023 - now

  • Lead Design Quality Engineer

    Apr 2022 - now

  • Project Lead -Medical Device Quality and Regulatory

    Jan 2021 - Mar 2022

  • Quality Engineering Project Lead

    Oct 2015 - Dec 2020

  • Medical Device Design Engineer

    Oct 2013 - Sept 2015