Job Title: GxP Validation Analyst
Location: Remote (USA)
Duration: Contract
Job Description:
We are seeking an experienced GxP Validation Analyst to support a global instrument software validation initiative involving over 200 laboratory instruments. The consultant will be responsible for documenting, validating, and assessing software installed on laboratory instrumentation in compliance with current EMA guidelines, while supporting the transition of software management to IT software management SOPs.
Key Responsibilities:
Gather and document business and system requirements
Develop and execute validation test cases
Create software specification documentation
Develop infrastructure and data flow diagrams
Perform risk assessments and impact analyses
Validate instrument software in accordance with EMA and GxP requirements
Support migration of instrument software management to IT governance processes
Collaborate with Quality, Laboratory, Validation, and IT teams globally
Required Skills:
Strong experience in GxP Computer System Validation (CSV)
Knowledge of EMA regulations and validation requirements
Experience with laboratory instruments and instrument software validation
Expertise in requirements gathering, risk assessments, and test case development
Experience creating technical documentation, infrastructure diagrams, and data flow diagrams
Strong understanding of SDLC, Quality Systems, and compliance standards
Location: Remote within the United States
Interested candidates, please send your resume to:
Keywords: GxP, CSV, Computer System Validation, EMA, Validation Analyst, Lab Instrumentation, Risk Assessment, Software Validation, Quality Compliance, Pharmaceutical, Life Sciences, FDA, GMP, Validation Engineer
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