4+ years of experience in Computer System Validation (CSV) in Pharmaceutical and Biotech Industry.Experience in 21 CFR part 11 (Electronic Signatures, Electronic Records, Audit Trails), 21 CFR part 210, 211 and 820, ISO 13485. Strong understanding in System Development Life Cycle (SDLC) and Validation Life Cycle (VLC). Expertise in developing and authoring User Requirement Specifications (URS), Functional Requirement Specifications (FRS) in compliance with Food and Drug Administration (FDA) Regulations. Good understanding of cGXP (Current Good Manufacturing Practice - cGMP, Current Good Clinical Practice - cGCP, Current Good Laboratory Practice - cGLP). Involved in performing Risk Assessment, System Level Risk (SLR) and Requirement Risk Assessment (RRA). Experience in authoring and executing Validation protocols (Installation Qualification –IQ, Operational Qualification – OQ and Performance Qualification – PQ). Prepared Requirement Traceability Matrix (RTM) and Test Summary Report (TSR). Excellent Knowledge and experience in Good Documentation Practices (GDP) and Data Integrity (DI) followed by the ALCOA+ principles. Knowledge on Corrective Action and Preventive Action plans (CAPA) & GAP Analysis and Highly interested to work on entire CAPA & GAP Analysis procedure.Good communication skills, excellent team player, Ability to work both independently and in a team-oriented working environment.