El Sobrante, California, United States
5+ years of experience in Validation with strong background in Computer System Validation, Technical Writing along with performing Manual and Automated Testing including specialization in 21 CFR part 210,211,820 compliance and GAMP, GxP’s (GMP, GLP and GCP). Experienced in authoring CSV Deliverables like SRS/URS/FRS, VP, RRA, RTM, VSR and executing Validation Protocol IQ/OQ/PQ. Extensive Knowledge of Data Integrity ALCOA and discrepancies and implantation of CAPA.Involved in Change Management and Risk Analysis concepts.Excellent communication and written skills