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Akshay Bihare

Akshay Bihare

Summer Intern

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  • Timeline

  • About me

    IT-CSV | IT-Compliance | 21 CFR | GAMP 5 | Data Integrity | GxP

  • Education

    • Little Flower High School Pathakhera

      -

    • SATI, Vidisha

      2016 - 2020
      Bachelor of Engineering - BE Electrical Engineering

    • Kendriya Vidyalaya

      -
      12 Mathematics and Computer Science

  • Experience

    • MPGCL Satpura thermal power plant Sarni Dist Betul (MP)

      May 2018 - May 2018
      Summer Intern

    • Bharat Heavy Electricals Limited

      May 2019 - Jun 2019
      Engineer Intern

    • INSTRUMENTATION AND CONTROL SOLUTIONS

      Jul 2021 - Apr 2024
      Executive

      Prepared and executed the planning to reporting documents e.g. GxPA Risk Assessment, System Requirement Specification (SRS), Functional Requirement specification (FRS), Electronic Data Compliances (EDC),Functional risk assessment (FRA), Installation Qualification (IQ), and Operational Qualification (OQ) Performance Qualification (PQ), Requirement Traceability Matrix (RTM) and Validation Summary Report (VSR).• Ensure that the Execution of all process complies with various Regulations like GAMP 5, 21 CFR Part 11, and EU annexure 11.• Perform the Data Backup/Archival and Restore/Retrieval of system including IPCs and PLC system as per applicable SOP as per site.• Working knowledge of GxP, GMP, GAMP, Show less

    • ATS Global

      Apr 2024 - now
      Validation Engineer

  • Licenses & Certifications

    • Internet of Things

      Udemy Free Courses

    • Autocad

      Internshala Training
      May 2020

    • Matlab

      Udemy
      May 2020