Total 9+ years of professional experience.

• Excellent experience with ETL tool –INFORMATICA 7.x/8.x/9.x, HotFix, ODI,Datastage,Abinitio,Talend,BIReady,Microstrategy,SAS DI Studio etc
• Expertise in data analysis using tools like, Tableau,Cognos,Qlikview,OBIEE,SAP-BI,SAS etc
• Report generation on the basis of data analysis for decision making
• Implementation and support for SAP Success Factors, SF-Module handling for implementation and support are RCM,LMS,PMS,EP.
• Involve in Data/Application Security, Control, Recovery/Restoration and Replica Creation of System/Application in order to meet business continuity.
• Strong project management skills with experience in internal and external relationship management and team skills. Align with Top management for IT Project/ERP progress review.
• Experience using GAMP 5 (Risk-Based Approach) to validate Computerized systems
• Experience in Validation and Management of Stability study analysis of various products
• Experience in writing OQ, PQ, System Acceptance and User Acceptance test scripts to validate systems in compliance with CFR Part 211,21
• Experience in writing SOPs, Working Documents, Batch reports and project reports
• Knowledge of Adverse Event Reporting System (AERS) for case data management and regulatory reporting in the pharmaceutical industry.
• Experience working on TrialWorks and Siebel Clinical Trial Management System (CTMS) designed specifically for day to day tracking and reporting of regulatory and clinical information
• Extensive Experience on Decommissioning and data archiving of system and related data for validated systems and processes
• Experience working as a Document Management system Administrator to maintain all validation documents in the central document repository.
• Experienced in preparing Quality Assurance audit reports and writing OOS documents
• Developed all GAMP required SDLC documentation for validation of SAP modules