Risk & Compliance Senior Analyst

Takeda Pharmaceuticals International AG; Chihuahua; Presencial; MXN 915,000 - 1,283,000; Jornada completa

Descripción de la vacante

A leading global healthcare company is seeking a Risk & Compliance Senior Analyst in Chihuahua, Mexico. The role requires 3+ years of experience in a similar position, focusing on capturing business and technology requirements. Successful candidates will have a Bachelor's degree in a relevant field and strong analytical, communication, and problem-solving skills. This position offers the opportunity to contribute to compliance and data integrity within laboratory and production systems.

Formación

• 3+ years of experience in a similar role.
• Strong knowledge of computer system validation.
• Understanding of regulatory requirements in the pharmaceutical industry.

Responsabilidades

• Engage with stakeholders to capture business and technology requirements.
• Support in the Validation Life Cycle of Computerized Systems.
• Draft and review validation plans and specifications.
• Conduct risk analysis and draft testing protocols.
• Execute validation tests and prepare phase reports.

Conocimientos

Analytical skills

Problem-solving skills

Communication skills

Collaboration skills

Attention to detail

Educación

Bachelor's degree in Life Sciences or Computer Science

Descripción del empleo

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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

• 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