Business Systems and Validation Analyst III
Core
Validating lab instrumentation in accordance with EMA guidelines and managing system development lifecycle deliverables.
Role type
Business Systems and Validation Analyst
Builds
System validation test cases, testing summary reports, and system diagrams
Domain
Life Sciences / Clinical Research / Regulatory Compliance
Required skills
System risk assessment, System validation test case creation, Testing summary report creation, System diagram creation, EMA regulatory guidelines knowledge, MS Office proficiency, Project effort estimation, Problem-solving, Analytical skills, Planning, Organizational skills, Clinical trials operational processes knowledge, Software development life cycle (SDLC) knowledge, SOPs/WPDs and process maps knowledge
Preferred skills
None stated
Technologies
MS Office
Responsibilities
Preform system risk assessments, Create system validation test cases and testing summary reports, Create system diagrams, Work on project timelines, Participate in client and regulatory inspections, Work closely with various departments and vendors
Seniority
Mid-level, individual contributor