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

Health Care

251-1K (780)

Founded 1984

8 open positions

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Validation Specialist II

2 hours, 11 minutes ago

Poland

Full-time

Mid Level

Manual QA Tester

Quality Assurance and Testing

Agile

Apply Now

Rho

Biotechnology

251-1K

Founded 1984

View All Jobs 8

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?

Apply directly on the company website

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