Validation Specialist
New
R
Rho IncClinical Research
PolandFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- English, local languages
- Experience
- 3 - 5 years
- Required Skills
- Project ManagementBusiness Analysis
Requirements
- Bachelor's degree or international equivalent
- 3-5 years of professional experience in clinical research industry
- Validation experience in a GxP environment
- Proficiency in validation methodologies, risk-based validation, and regulatory expectations
- Working knowledge of 21 CFR Part 11
- Proficiency in Microsoft Office suite (Word, Visio, PowerPoint, Project, SharePoint, Excel) and Adobe Acrobat
- Strong written, verbal, and presentation communication skills
- Fluency in English and local languages
Responsibilities
- Define and document requirements and business processes
- Identify and schedule project deliverables, milestones, and tasks
- Research, develop, and write content for software validation
- Prepare and maintain user, system, and validation documentation
- Lead or participate in developing SOPs for regulatory compliance
- Ensure adherence to SOPs and quality assurance plans
- Act as an independent quality reviewer
- Create and execute acceptance tests
- Coordinate recruitment, training, and testing of qualified testers
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