Experience, Rho. A global full-service CRO.
Validation Specialist II/III
Location
Poland
Posted
1 day ago
Salary
0
Seniority
Senior
Job Description
Validation Specialist II/III
Rho
• Perform business analysis, validation, and testing processes to support software development in regulated clinical research • Direct validation testing to ensure final outcomes meet specified requirements • Ensure and facilitate corporate compliance with applicable regulations concerning software development and maintenance • Work closely with business primes to document requirements and business processes • Identify and schedule project deliverables, milestones, and tasks for software validation • Research, develop, and write validation content for software products and services • Prepare and maintain documentation relating to users, systems, programming, and validation • Create graphical images, flow charts, and diagrams for documentation • Develop and/or participate in SOPs to ensure regulatory compliance • Ensure adherence to SOPs, regulatory validation, and quality assurance plans • Act as an independent quality reviewer for peer software validations • Ensure developed application documents meet project and SOP requirements • Ensure compliance with testing environment requirements for validation testers • Create and/or execute acceptance tests for software under development or commercial products • Coordinate recruitment, training, and testing of qualified testers for acceptance testing
Job Requirements
- Bachelor's degree or international equivalent required with a minimum of 3 - 5 years of professional work experience is required within the clinical research industry; or an equivalent combination of relevant and preferred education and/or work experience
- Validation experience in GxP environment is required
- Demonstrates strong proficiency in validation methodologies, risk‑based validation, and regulatory expectations with minimal supervision
- Working knowledge of 21 CFR Part 11 regulations and a project management background is helpful
- Microsoft Word, Microsoft Visio, Microsoft PowerPoint, Microsoft Project, Microsoft SharePoint, Microsoft Excel, Adobe Acrobat
- Must have the ability to work as part of a cross-disciplinary team and to communicate and relate to a diverse number of co-workers
- Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s. Fluency in both English and local languages.
- Committed to Quality: Every job at Rho requires an attention to detail, a deep understanding of our high-quality scientific standards, and an ability to care about every outcome.
- High-Character: Contribute to our collaborative culture with honesty and integrity. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust. We work smart together, we work hard together, and we laugh together. We take responsibility for our actions, forgive honest mistakes and respect one another.
- Critical Thinker: Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience. We evaluate situations and opportunities objectively and incisively; we then craft novel, practical solutions.
- Agile and Adaptable: Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment. We embrace risk but manage it by planning, accepting, and learning from both failures and successes. The opportunity to adapt and evolve energizes us.
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