Job Summary
As part of the Io T application development team, the Io T Product & Compliance Mgt Specialist, Digital and Transformation, participates in the design, development, validation, and support of West Io T applications with a focus on Gx P-compliant computerized system documentation and processes, primarily in English. The specialist will be responsible for owning the documentation artifacts and ensuring alignment with Computerized System Validation (CSV) lifecycle requirements while maintaining compliance with regulatory expectations and West quality standards. Working closely with an international team, the individual will help drive the validation readiness and continuous improvement of West’s Gx P-relevant Io T applications within manufacturing and digital operations.
Essential Duties and Responsibilities Manage the document lifecycle for Gx P computerized systems, covering design, development, testing, validation, release, and change control documentation
Prepare, revise, and maintain technical validation deliverables such as Functional Risk Assessment (FRA), Functional Specification (FS), Design Specification (DS), Requirements Traceability Matrix (RTM) and relevant technical work instructions, ensuring alignment with Gx P and data integrity expectations
Collaborate with global cross-functional teams within the company, including Quality, Validation, Business and IT, to support CSV activities and ensure consistency with validation objectives and regulatory guidance
Other duties as assigned
Education Bachelor’s degree in English or technical field preferred
Work Experience 2+ years of experience in Gx P computerized system documentation, validation support, or quality compliance roles within a regulated industry preferred
Preferred Knowledge, Skills and Abilities Excellent written and verbal communication skills in both English and Mandarin
Solid understanding of Gx P principles, CSV lifecycle, and associated documentation controls
Ability to prepare, review, and manage system deliverables that demonstrate compliance with validation and quality requirements
Experience with Agile software development practices and tools such as Azure Dev Ops or Jira is a plus
Familiarity with Io T systems, automation platforms, or cloud-based applications in a regulated context is an advantage
Working knowledge with GAMP 5, 21 CFR Part 11, and EU Annex 11 is a big plus
Strong organizational skills with an ability to prioritize multiple deliverables and manage communications efficiently
Ability to collaborate effectively in a global matrixed organization, bridging technical, business, and quality functions to ensure compliant system delivery
Ability to work autonomously in a fast-paced and complex environment with a self-motivated work ethic; use sound judgment with an ability to manage multiple priorities with a sense of urgency
Able to comply with the company’s safety and quality policies at all times
