Skills Summary A Senior Software Professional who has exceptional project management, client relationship and leadership skills with a proven track record of managing multiple projects with multiple stakeholders and multi-disciplinary teams delivering projects on time, on budget and to the client's satisfaction. * A certified PMP having 20+ years of Software Engineering experience that includes: * Project Management and Stakeholder interface, Co-ordination and PMO operations * Budget Management, spend forecasting, resource burn hour tracking and invoicing * Risk Identification and mitigation planning * Business and System Requirement capture, Workflow Analysis, Gap identification and analysis, Design, Development, and Validation * Solid Knowledge Computer System Validation (CSV) and on Regulatory Processes (FDA - 21 CFR Part 11, GMP, GLP and GCP Validation and compliance audit) * Regulatory management of important timely issues and the impact on the global program. * Comprehensive knowledge of International Drug Safety and Pharmacovigilance principles and regulations and case processing * Strong Knowledge of Software Development Life Cycle (SDLC) and Agile methodologies * Experience and knowledge of Client Management, Change Management, Risk assessment and mitigation planning * Implementation of Laboratory Information Management System including QA and QC Experience * Strong Knowledge and experience in Pharmaceutical Industry Strong Knowledge on Implementation of Chromatography Data System (CDS) - Empower2 * Good working knowledge on NuGenesis Scientific Data Management System (SDMS) * Good hands-on experience in Data Migration from legacy systems to new implemented system * Solid knowledge and experience in Creation and validation of IQ, OQ and PQ documents * Strong Knowledge and Experience in Pharmaceutical Quality Compliance and Management * Strong Use Case documentation experience * QA/Testing expertise includes Integration, Functional, System, Regression, End to End and User Acceptance Testing * Software Product Vendor Assessment and Evaluation * Possess strong written and verbal communication and inter personal skills. * A good Project Manager/ Coordinator/Mentor /Team player an open mind to learn new technologies.
Description
