Mudit Kumbhkar

Experience

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  Infosys

  Mar 2010 - Feb 2015

  • Worked under the Life Sciences Unit as a Compliance and Audit professional. • Handled client engagements related to Internal Audits, Process risks, Process compliance and reviews, GxP Compliance, SOX Compliance, Standard Operating Procedures manuals & Enterprise Risk Management. • Worked as Consultant role in executing projects for various applications for major global Clients in the Life Sciences domain. • Client engagement – Ensured quality delivery as per client requirements. • Suggested ideas on improving engagement productivity and identify opportunities for improving client service. Hands on experience of Service Improvement Plans • Ensure compliance with engagement plans and internal quality & risk management procedures. • Played role of Project Quality Manager (CSV) for Pharmaceutical Clients. • Developed strong working relationships with client (process owner/functional heads). • Involved with Center of Excellence and worked on eQMS using TrackWise Systems. • Attention to detail and mentor young interns and analysts within the unit. • Contribute to knowledge management sessions within the unit. Show less

  • Associate Business Analyst

    Jul 2014 - Feb 2015

  • Senior Systems Engineer

    Jul 2012 - Jun 2014

  • Systems Engineer

    Mar 2010 - Jun 2012
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  SUN PHARMA

  Mar 2015 - Aug 2015

  Senior Executive - IT Validation

  • Responsible for CSV activities related to IT Infrastructure Qualification, Manufacturing Systems and Lab Systems across multiple manufacturing sites• Guide users for GxP, GAMP 5, 21 CFR Part 11 and other regulatory requirements to help in smooth validation activities for the systems• Involved in PLC/ SCADA system validation• Worked on responses for TGA audit and other Pharma audit (PAREXEL and Lachman) observations• Involved in SOP revisions and trainings for the users on various SOPs Show less

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  Freyr Solutions

  Sept 2015 - Dec 2015

  Senior Associate - Compliance and Validation

  • Worked on developing CSV SOP; ITIL Process SOPs (Change Management, Problem Management, and Incident Management); CAPA; Deviation Management.• Worked on retrospective validation of the company internal tools.• Guided project team for GAMP 5, 21 CFR Part 11 and Annex 11 regulatory requirements to help in smooth validation activities for the system.

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  Ciber Global

  Jan 2016 - Mar 2017

  Senior Consultant - CSV

  • Assigned to Philips Health Tech project as Validation Engineer.• Involved in setting up leaner Quality Management System • Worked as SME and validation personal for validating Validation Lifecycle Management System - ValGenesis• Involved as an individual contributor and part of Philips IT Validation CoE as a Validation Engineer, managed validation activities by interacting with cross-functional teams and tracking activities to closure • Worked on validation activities for projects following agile methodology and cloud concepts• Involved in authoring training materials and user manuals for role based training of end user on process and VLMS tool• Imparted training on the Computer System Validation process and VLMS (ValGenesis) tool• Involved in drafting strategies for the Lead Deployments and Mass Deployments as well as managed System Change Requests.• Key Responsibilities included:o Authoring Validation Plan, Test Plan, Tractability Matrix, Test Summary Reports, Validation Summary Reporto Reviewing all validation deliverables and executed test protocols Show less

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  SUN PHARMA

  Apr 2017 - Apr 2021

  Manager - CSV

  • Lead IT Validation activities across multiple locations (5 Manufacturing and R&D Locations)• Responsible for defining overall Validation Strategy of IT projects to be implemented for supported sites – in Labs, Manufacturing areas and Enterprise solutions.• Handled regulatory audits for the supported sites (sites responsible for Drug Formulation and API Manufacturing) • Involved in implementation/validation of following key projects: Manufacturing Execution System (harmonization of Report and DB backups of process control systems), AI based Lab System, Automated Warehouse, Paperless Validation System, Robotic Process Automation and Electronic Document Management system.• Evaluated project against regulatory and IT risk for defined requirements to ensure compliance. Show less

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  Novartis

  May 2021 - now

  Project Quality Management Expert