At Takeda, we are guided by our purpose of creating better health for people and a brighter future for the world. Every corporate function plays a role in making sure we — as a Takeda team — can discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planetAbout the role:The Technical Business Analysis, Analyst II engages with diverse stakeholders to capture both business and technology requirements for defined solutions. This role helps improve business processes through new technology or alternative uses of existing technology, contributing to Takeda's missionSupport in the Validation Life Cycle of Computerized Systems with special attention to laboratory and R&D systems: Drafting of Validation Plans; Drafting and Review of Specification documentationSpecification of User RequirementsRisk AnalysisDrafting of DQ, IQ, OQ and PQ testing protocolsExecution of validation tests and the phase reportsProvider support during systems implementationDrafting and Review of Standard Operating Procedures (SOP)Acting of IT/QA Compliance: Evaluation of the State of compliance of the Computerized Systems with respect to the requirements of Data Integrity. Proposal for remedial actions based on the level of risk associated with the GAPs foundSupport and execution of Data Integrity Compliance remediation actions on Laboratory and Production SystemsReview of generated validation documentationPreparation/updating of Policies, SOPs, Standards and Validation Templates regarding standards and Corporate PoliciesReview of Validation documentation regarding compliance with SOPs and approved validation standardsQualifications3 years of experience in a similar roleBachelor's degree in a relevant field (e.G., Life Sciences, Computer Science)Preferred, experience in computer system validationPreferred, knowledge of regulatory requirements and guidelines applicable to the pharmaceutical and biotechnology industryStrong analytical and problem-solving skillsExcellent communication and collaboration skillsAttention to detail and a commitment to data integrity and quality#J-18808-Ljbffr