Validation Specialist II

2 months ago
Full-time
Mid Level
Quality Assurance and Testing
Rho

Rho

Rho is a full-service Contract Research Organization (CRO) that combines innovation and scientific rigor to maximize results in every phase of clinical research. With a global team of experts, Rho ensures consistent and efficient trials, offering compr...

Biotechnology
251-1K
Founded 1984

Description

  • Work with business stakeholders to define and document requirements and business processes for clinical trials software.
  • Identify and schedule project deliverables, milestones, and validation tasks for software releases.
  • Research, write, and maintain validation content and supporting documentation for software products and services.
  • Prepare and maintain documentation for users, systems, operations, products, services, testing, and validation.
  • Create graphical images, flow charts, and diagrams for inclusion in validation documentation.
  • Develop and support SOPs that ensure regulatory compliance for software development and implementation.
  • Ensure software developers and customers follow SOPs, regulatory validation requirements, and quality assurance plans.
  • Review peer validation work independently and accept quality reviews of your own documentation to support audits.
  • Verify that application documents meet project requirements and SOP standards.
  • Ensure testing environments meet validation requirements and create or execute acceptance tests for software and commercial off-the-shelf products.
  • Coordinate the recruitment, training, and execution of acceptance testing by qualified testers for new software releases.

Requirements

  • Bachelor’s degree or international equivalent is required.
  • 3–5 years of professional experience in the clinical research industry is required, or an equivalent combination of education and experience.
  • Validation experience in a GxP environment is required.
  • Strong proficiency in validation methodologies, risk-based validation, and regulatory expectations is required.
  • Working knowledge of 21 CFR Part 11 regulations is helpful.
  • Project management background is helpful.
  • Experience with Microsoft Word, Visio, PowerPoint, Project, SharePoint, Excel, and Adobe Acrobat is required.
  • Ability to work as part of a cross-disciplinary team and communicate effectively with diverse coworkers is required.
  • Strong written, verbal, and presentation skills in English are required.
  • Fluency in both English and local languages is required.
  • Must submit CV/resume in English.
  • Experience demonstrating attention to detail, critical thinking, adaptability, and a quality-focused mindset is expected.

Interested in this position?

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