Risk & Compliance Senior Analyst

Please be aware of identity thieves actively posing as Takeda employees or recruiters posting Takeda-branded jobs online to steal personal information from job seekers., We care about your privacy and candidate experience. about how to spot fraudulent messages here

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 planet

About the role :

• The Risk & Compliance Senior Analyst 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 mission
• Support 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 documentation
• Specification of User Requirements
• Risk Analysis
• Drafting of DQ, IQ, OQ and PQ testing protocols
• Execution of validation tests and the phase reports
• Provider support during systems implementation
• Drafting 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 found
• Support and execution of Data Integrity Compliance remediation actions on Laboratory and Production Systems
• Review of generated validation documentation
• Preparation / updating of Policies, SOPs, Standards and Validation Templates regarding standards and Corporate Policies
• Review of Validation documentation regarding compliance with SOPs and approved validation standards

Qualifications

#J-18808-Ljbffr