Nageswara Pacha
Validation Specialist Consultant @Regeneron
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WORK HISTORY
Validation Specialist Consultant @Regeneron
Rensselaer, NY, US
EDUCATION
Tamil Nadu Doctor M.G.R. Medical University
Master’s Degree, Pharmaceutical Analysis
Tamil Nadu Doctor M.G.R. Medical University
Bachelor’s Degree, Pharmacy
Texas A&M University-Kingsville
Master’s Degree, Chemistry
ABOUT NAGESWARA PACHA
Experienced Validation SME in oversee Lab Equipment Qualification, Cleaning Validation, Sterilization (SIP) Validation, Process Equipment Qualification, Computer System Validation, Utilities Qualification, and Temperature Mapping Studies. Authored Validation Master Plan (VMP), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Risk Assessments, Commissioning, Protocols such as Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Requirements Traceability Matrix (RTM), Standard Operating Procedures (SOP) and Validation Summary Report (VSR). Authored and executed IQ, OQ, and PQ protocols. Authored Summary Reports. Performed 21 CFR Part 11 and Annex 11 Assessments and Data Integrity Assessments (DIA). Experience with 21 CFR Part 210, 211, ASTM E2500, USP1058 and GAMP categorization. Handle Deviations, Change Controls and CAPAs.
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