SUMMARY Over 6 years of experience as a Business Systems Analyst in Pharmaceutical and Medical Devices industries with comprehensive understanding of GxP Regulations. Good understanding of various System Life Cycle models, Waterfall and Agile methodologies. Participated in all phases from analysis, design, and development through testing, implementation and change control. Experienced and proven ability acting as liaison between IT and the business. Authored Requirement Specification documents (URS, FS) and functioned as liaison with Technical Teams to develop System Design Documents. Solid understanding of On-Premise as well as SaaS (Software As A Service) applications. Excellent experience in creating the following deliverables as a Business Analyst - User Requirements Specifications, Functional Requirements Specifications, Configuration Specifications, User Manuals, Operations Process Manuals, Account Request Forms, Change Controls, User Acceptance/System Integration Test Plans and Problem Reports. Excellent experience in leading Conference Room Pilots (CRPs), Requirements gathering workshops and Working sessions with Suppliers. Outstanding experience in using tools like MS Visio, Word, PowerPoint, Excel, EDraw Max, Axure and UML Tools for realizing multifaceted business processes into precise, testable requirements. Thorough understanding of System Development Life Cycles for FDA regulated applications. Experienced working in Waterfall and Agile/Scrum SDLC methodologies. Expertise in writing Installation Qualification (IQ) protocol, Operational Qualification (OQ) protocol, Performance Qualification (PQ) protocol and Standard Operating Procedures (SOPs). Expertise in providing Good Documentation and Testing Practices training to Business Users to help them execute PQ testing. Excellent Presentation, decision-making, and organizational skills Proficient in performing validations including Prospective and Retrospective Validation. Extensive experience in developing Test Plan, Test Cases and Test Summary Report. Well versed in documenting and executing Test Scripts (IQ/OQ/PQ Test Scripts), Deviations and Change Controls. Excellent documentation skills in compliance with Good Documentation Practices (GDP). Experience in performing Gap Analysis, reviewing and performing Corrective and Preventive Action (CAPA) and suggesting Remediation Plan to mitigate non-compliance. Expertise in using Documentum, SharePoint, Trackwise, MS Word, MS Visio, PowerPoint and Excel Spreadsheets for performing day to day operational activities. Knowledge and experience with automated testing tool: Quality Center/ALM. Involved in preparation of User procedure and System Admin SOP's for spreadsheets. Strong knowledge about Pharmaceutical/Medical device regulations like FDA: 21 CFR Part 11, 21 CFR Part 211 and 21 CFR Part 820. Strong knowledge and background of Software Development Life Cycle (SDLC) and Validation Life Cycle (VLC). Familiar with Waterfall, Agile, Spiral and V-model. Good knowledge and working experience with cGxP (GMP, GCP, GLP, and GAMP) standards. Good understanding and practical knowledge on GAMP 4 and GAMP 5 regulations. Team player with excellent communication and leadership skills with the ability to interact with people at all levels. Innovative thinking and strong problem solving skills.

Highlights:

• ACD
• Applications
• Asset Liability Management
• Asset Management
• Automatic Call Distribution
• Benefits
• Business Analysis
• Business Analyst
• Business Requirements
• CFR Part 11