Chandu Kattula

Experience

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  Bharat Biotech

  Sept 2014 - Nov 2015

  Validation Analyst

   Performed User and Business Requirements analysis to prepare Validation Master Plan. Performed Positive and Negative Testing of the application. Written IQs, OQs, PQs and documented results in compliance with FDA regulations. Involved in validation of Laboratory LIMS, Manufacturing Automation Systems, TrackWise, ERP Systems.

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  Adaptimmune

  Feb 2016 - Feb 2018

  Validation Analyst

   Created Installation and Operational Qualification Protocols (IQOQ) and executed them to verify System Security, Audit Trails, User Role based Access and settings. Involved in performing GAP Analysis to be compliant with 21 CFR Part 11, Security and Data Integrity requirements and Good Documentation Practices (GDP). Prepared Requirements Traceability Matrix (RTM) to determine that all the User and Functional requirements have been covered in the protocols and provide traceability between them. Created the Validation Summary Report (VSR) documents to summarize the performed and completed activities in each phase of the project. Show less

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  Kanap systems llc

  Oct 2017 - now

  Validation Engineer
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  Tris Pharma

  Feb 2018 - Jun 2021

  Validation Engineer
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  ThermoFisher Scientific

  Jul 2021 - now

  Validation Engineer