Varshitha Reddy

About Varshitha Reddy

Data Analyst

Experience

1. Validation Engineer

   bioMérieux

   Oct 2023 — Present · Raleigh, NC, US

   Authored and executed qualification protocols for various benchtop equipment’s such as balances, tube welders, bio welders, tubing sealers and centrifuges. Conducted various smoke studies to study the air flow pattern for BSCs (Biosafety Cabinets), Laminar Airflow Pass Throughs & whole room smoke study.• Generation, execubtion and final report generation for laboratory and production instrumentation validation protocols (IQ, OQ, PQ) including Single use bioreactors, Incubators and Freezers, LIMS, Track wise etc.• Participated in system classification activities as part of the CQV framework, ensuring proper categorization of systems based on regulatory compliance and operational requirements.• Developed and executed Computer System Validation (CSV) documentation in compliance with 21 CFR Part 11, GxP, and GAMP 5 for laboratory systems such as LIMS, Track wise, and Documentum. • Validated computerized systems used in pharmaceutical manufacturing, ensuring compliance with regulatory standards and improving data integrity.• Worked extensively with Laboratory Information Management Systems (LIMS), along with other related systems like Documentum, which involve complex data management and have the capability to understand and manage Master Data related to laboratory operations.• Qualification and final report generation of Production area and qualification of gases such as CO2, O2, N2. • Familiarity with utilities (e.g, HVAC, clean rooms, water systems), process equipment validation.