Sudha channamalle

Labware LIMS Validation Lead at Radiance Technologies
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Contact Information
us****@****om
(386) 825-5501
Location
Bengaluru, Karnataka, India, IN

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Experience

    • United States
    • IT Services and IT Consulting
    • 1 - 100 Employee
    • Labware LIMS Validation Lead
      • Apr 2023 - Present

    • India
    • IT Services and IT Consulting
    • 1 - 100 Employee
    • Senior Software Engineer
      • Feb 2022 - Apr 2023

      • 21 CFR part 11 interpretations • GDP (Good Documentation Practices). • CSV activities of Labware LIMS V8 • Preparation of Validation/ Qualification documents as per VMP. • Preparation of User requirement specification. • Preparation of GxP Impact Assessment. • Preparation of Functional Risk Assessment. • Preparation of Installation Qualification according to servers. • Preparation of Test cases for Operation Qualification Like User management,Master data creation,Lot management,Standard and Inventory management,Creation of User privileges,Instrument interphase. • Preparation and training for Performance Qualification. • Preparation of Traceability Matrix. • Preparation of VSR Validation summary report. • CSV for Chromeleon 7.3.1 upgradation • CSV for Sparta Track wise for Deviation, Change control Initiation, CAPA modules • Sound knowledge in the analytical related software’s (LABWARE LIMS). Show less

    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Assistant Manager(QC-Stability)
      • Sep 2018 - Nov 2021

      Stability Data management, Involved in Analytical Instrument Qualifications Stability Data management, Involved in Analytical Instrument Qualifications

    • Canada
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Sr.Research Scientist
      • May 2008 - Aug 2018

      Labware LIMS V5, Master Data creation CSV on Empower 3 and Custom field calculation Labware LIMS V5, Master Data creation CSV on Empower 3 and Custom field calculation

    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Quality Control Officer
      • Jan 2007 - Apr 2008

Education

  • Gulbarga University
    Master's degree, Microbiology, General
    2004 - 2006

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