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Varun KanukuntlaVK

Varun Kanukuntla

Computer System Validation Specialist

€650/day
Eindhoven, NL
8-15 years

Average response time: 1 hour

About Varun

Experienced Computer System Validation professional with a proven track record of ensuring compliance with global and local company policies, procedures, and legal requirements for clinical trials. Adept at applying GxP practices, GAMP categories, and following 21 CFR Part 11 FDA regulations for electronic records and electronic signatures. Skilled in executing all phases of computer system validation for production, QC lab, MO lab, and AR lab systems, including data integrity verification, compliance analysis, risk assessment, and preparation of technical and GMP-related documentation. Proficient in validating MES systems, DCS systems, Excel spreadsheets, and executing NPI activities. Experienced in using Kneat, AGILE DMS, and JIRA validation software to create and execute test plans in the medical device industry.
  • English

    Native or bilingual

  • Dutch

    Basic

  • Hindi

    Native or bilingual

  • Telugu

    Native or bilingual

Can work on-site
Eindhoven (up to 50km), Groningen (up to 100km)

Experience

  • Johnson & Johnson
    Senior IT Validation Consultant
    MEDICAL
    March 2018 - Today (8 years and 3 months)
    Groningen, Netherlands
    Collaborating with businesses to understand and formulate product requirements for qualification
    Preparing validation and compliance plans to meet FDA industry standards
    Working as a CSV Remediation Engineer, having knowledge of complex systems such as HPLC, GC systems, Endosafe, Rheometer, TOC Analyzer, etc.
    Validating COTS, configured, and custom coded applications
    Understanding and communicating cGMP, Part 11 requirements, and ISO standards to business users
    Estimating data integrity and complexity of systems and conducting risk assessments for non-conformance
    Preparing User Requirements specifications, IQ/OQ/PQ documents, and Compliance Summary Reports
    Validating systems with business users for compliance and executing approval processes with stakeholders
    Working with AWS and Azure clouds and applying security measures with OpenVPN module.
    Microsoft Word Microsoft Excel IT Masterplan Agile Methode Scrum Atlassian JIRA Jenkins Azure DevOps Microsoft Powerpoint
  • Tech Mahindra
    Senior Software Engineer
    May 2015 - March 2018 (2 years and 10 months)
    The Hague, Netherlands
    1. Working in DevOps with Agile Methodology making an integrated and continuous delivery model for quality and business extensibility. 2. Worked well on the JIRA Atlassian Tool for Sprint requirements in Agile Methodology and administering JIRA for the team. 6. Development of several add-ins corresponding to various functionalities in Click Schedule WebClient, Click Scheduler Client, Click Mobile Classic and Click Mobile Touch applications as per business requirements. 7. Design Preparation and walkthrough sessions to business and conducting demo sessions for requirements developed in the Release. 8. End to end application Click Software configuration which include Structure Tool, Click Administration Tool, Click Scheduler Client, Click Web Client, Click Mobility Studio, Click Installer Tool and Click Builder Tools. 9. Customizations using C#, Silverlight, Asp.Net, JavaScript, JQuery and other Web based technologies. 10. Development of requirements in .NET using C# and ASP.Net for server side components. 11. Development of requirements in .NET using Silverlight, Javascript and Script # for client side applications. 12. Development of requirements at database level using PL/SQL Programming, created triggers and indexes. 13. Testing in all phases include Unit Testing, Regression Testing , System Testing and Chain Testing for the proper functioning of the application. 14. Deployment of successful monthly releases for KPN business, schema and configuration changes for Click Product and its modules. 16. Supported the business for incidents and problem solving in critical issue scenarios for business smoothening. 17. Played role in analyzing the incidents on a daily basis and provide solutions to enhance the effectiveness of the Application. 18. Keeping track of the incidents and their solutions in place for Product enhancement. 19. Providing solutions for Problem Tickets and Change Requests which are raised by business for Application efficiency.
  • Accenture
    Software Engineer
    July 2014 - April 2015 (9 months)
    Bengaluru, Karnataka, India
    1. Involved in business discussions for requirements understanding and Knowledge Transfer sessions. 2. Imparting the understanding of the requirements to the team for implementation and questionnaire. 3. Development of the functionalities with C#, ASP.NET, Silverlight, ADO.NET, Javascript for UI front end development. 4. Worked in Salesforce, Workforce Management and Planning Tool for planning the capacity of the organization and configuring the application end to end. 5. Development of several add-ins corresponding to various functionalities in ControlCenter and Click Mobile applications as per business requirements. 6. Back end development to build the business logic using C#, ADO.NET technologies. 7. PL/SQL Programming for Stored Procedures and Functions in Oracle 10g databases and SQL Server. 8. Unit Testing, Chain Testing and Regression testing manually of the user stories/requirements and providing deliverables using automation tools by batch scripting. 9. Application code is checked and versioned in Tortoise SVN and also adhered using FxCop Tool. 10. Design Preparation of the functionalities and Deployment deliverables from Release to Release in Agile Methodology. 11. Post Production deployment Support and ensuring the standard of the Production environment is stable. 12. Analyzed the incidents on a daily basis and provide solutions to enhance the effectiveness of the Application 13. Keeping track of the incidents and their solutions in place for Product enhancement. 14. Providing solutions for Problem Tickets/Change Requests which are raised by business for Application efficiency. 15. Analyzing new requirements and problems related to application and providing solution for business continuity. 16. Testing in all phases for the proper functioning of the application. 17. Deployment of successful monthly releases for Enbridge, schema and configuration changes for Click Software and Enbridge Releases

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Education

  • Bachelor of Engineering
    Birla Institute of Technology
    2011
    Bachelor of Engineering (BEng), Electrical and Electronics Engineering

Skill set (25)

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