Nabi Rasool

Background

About Nabi Rasool

Experienced in Validation of IT Applications and Systems to ensure Compliance with the Life Sciences Industry Regulations • End to End exposure to Computer System Validation Process • Good knowledge of Computer Software Assurance • Experienced in both Review and Creation of Validation deliverables and System Operational Documentation • Excellent exposure to the Waterfall and Agile SDLC and Good knowledge of GxP requirements. Firm understanding of validation and testing activities with focus on Process Improvement • Good knowledge in GAMP guidelines, GAP Assessment, 21 CFR Part 11, Annex 11, SDLC and Computer System Validation requirements and deliverables ranging from Validation Plan/Protocols, IQ, OQ, PQ, Reports, various Assessments, SOPs, CAPA and others. • Risk Assessment, Validation Strategy, SOP, Process Improvement, Change Management, CAPA and Deviation management, Test & Defect Management, Gap Analysis, GxP Assessment, Nonconformance Management, Agile (Scrum), GxP Regulations, Data Integrity • Managed delivery teams across projects spread across different geographical locations • Hands on experience of tools like HPQC/HPALM, Atlassian JIRA/X-ray, ETS Trackwise