Bharti S. Email & Phone Number

Project Co-ordination & Management| business analysis| Computer System Validation IT1. Implementing complex IT enterprise applications such as Artwork Management, Document Management System, Regulatory Management System, paperless validation, QMS, Serialization, Sage ERP, Clinical Volunteer Database Management System,etc. in liaise with product partners. Working knowledge of Argus, talk desk, Sharepoint, etc.2.Providing operational/admin support for IT applications.3.Handling multiple internal and external teams.4.Vendor Management 5. Team mentoring & Training6. Setting up admin proceduresCompliance and CSV1. Good knowledge in Part 11 and Gamp 52.Proficient in reviewing, assisting and creation of Computer System Validation documents like User Requirement Specification, Functional Specifications, Functional Risk Assessments , Requirements Trace-ability Matrix, OQ/PQ Test Protocols, Test Plan, Test Reports and Validation Summary Reports.3.Preparation of Training modules/Questionnaires for implementing CSV processes.4. Ensuring Data Integrity & adopting risk based approach