Sudha channamalle
Labware LIMS Validation Lead at Radiance Technologies- Claim this Profile
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Bio
Experience
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Radiance Technologies
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United States
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IT Services and IT Consulting
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1 - 100 Employee
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Labware LIMS Validation Lead
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Apr 2023 - Present
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Candor Software Solutions
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India
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IT Services and IT Consulting
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1 - 100 Employee
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Senior Software Engineer
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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
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Medreich Limited
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Pharmaceutical Manufacturing
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700 & Above Employee
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Assistant Manager(QC-Stability)
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Sep 2018 - Nov 2021
Stability Data management, Involved in Analytical Instrument Qualifications Stability Data management, Involved in Analytical Instrument Qualifications
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Apotex Inc.
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Canada
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Pharmaceutical Manufacturing
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700 & Above Employee
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Sr.Research Scientist
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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
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Medreich Limited
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Control Officer
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Jan 2007 - Apr 2008
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Education
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Gulbarga University
Master's degree, Microbiology, General