Risk & Compliance Senior Analyst

Risk & Compliance Senior Analyst

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Job Description

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.

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

Locations

MEX - Santa Fe

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Seniority Level

Mid-Senior level

Employment Type

Full-time

Job Function

Legal

Industries

Pharmaceutical Manufacturing

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