Risk & Compliance Senior Analyst

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Job Description

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.

Key Responsibilities

• 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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