West Pharmaceutical Services

Specialist, Product and Compliance

West Pharmaceutical Services

full-time

Posted on:

Location Type: Office

Location: Taichung • 🇹🇼 Taiwan

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Job Level

JuniorMid-Level

Tech Stack

AzureCloudIoT

About the role

  • Manage the document lifecycle for GxP 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 GxP 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

Requirements

  • Bachelor’s degree in English or technical field preferred
  • 2+ years of experience in GxP computerized system documentation, validation support, or quality compliance roles within a regulated industry preferred
  • Excellent written and verbal communication skills in both English and Mandarin
  • Solid understanding of GxP 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 DevOps or Jira is a plus
  • Familiarity with IoT 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
Benefits
  • Supported by benefit programs
  • Empower physical, mental, emotional and financial health of team members and their families
  • Committed to giving back to the communities
  • Sustainability efforts

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
GxP computerized system documentationvalidation supportFunctional Risk Assessment (FRA)Functional Specification (FS)Design Specification (DS)Requirements Traceability Matrix (RTM)GxP principlesCSV lifecycleGAMP 521 CFR Part 11
Soft skills
written communicationverbal communicationorganizational skillscollaborationself-motivated work ethicjudgmentability to prioritizeability to manage communicationsability to work autonomouslyability to bridge functions