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 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 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
3 years of experience in a similar role
Bachelor's degree in a relevant field (e.g., Life Sciences, Computer Science)
Preferred, experience in computer system validation
Preferred, knowledge of regulatory requirements and guidelines applicable to the pharmaceutical and biotechnology industry
Strong analytical and problem-solving skills
Excellent communication and collaboration skills
Attention to detail and a commitment to data integrity and quality
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