Validation Analyst
Current1.Understand Business requirements and participate in the designing of system assessments (Regulatory, Data Integrity and Cloud Assessments) along with Business and IT. 2.Responsible to create Computer System Validation (CSV) Strategy considering 21 Code of Federal Regulations (21 CFR Part 11) FDA, EU, Japan regulatory compliance, Business and Functional requirements.3.Responsible for executing change requests of the Commercial area applications by designing required validation deliverables which includes requirements, executable protocols, and non-executable documents. Understanding of Otsuka Change Management System ‘ServiceNow’ and perform the tasks in the system in order to implement the changes in Validated Environments.4.Responsible to perform validation activities of the Life Science applications in the Commercial area such as Otsuka Patient Support Salesforce Health Cloud, Informatica, Veeva PromoMats and Veeva CRM applications.. 5.Create Testing and Validation deliverables, Work for Change Request process Deviations and Corrective Action Preventive Acton (CAPA) using TrackWise system.6.Perform, business and functional acceptance testing which involves ensuring technical specifications and meet business requirements, Responsible for preparation of validation documents like Validation Plan (VP), Installation Qualification Protocol (IQP), User Acceptance Test Protocol (UATP), Operational Qualification Protocol (OQP), Performance Qualification Protocol (PQP), Requiremnt Traceibility Matrix (RTM) and Validation Summary document as per the classification of Good Automated Manufacturing Practice (GAMP) 5 and US FDA, European Union (EU), Health Insurance Portability and Accountability Act (HIPAA), Good Documentation Practice (GDP) guidelines.7. Responsible for review and approvals of the CSV documents in ValGenesis and Review/monitor defect management for system deviations from reporting till closure 8.Co-ordinate with end users to execute the UATP
