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Validation Resources

Fort Washington, Pennsylvania, United States
January 21, 2019


Duration - 4 - 6 months Experience 7-8 yearsLocation – Fort Washington, PAa) Provide guidance, interpretation, and ensure compliance with CSV-related regulations, quality manuals, company policies, and proceduresb) Responsible for authoring GxP computer validation and Part 11 related documentation (Assessments, Plans, FRS etc.)c) Develop, write and execute protocols, as neededd) Interface with internal partners to analyze data and situations leading to sound decision makinge) Support site CSV related initiatives and remediation activities including Part 11 compliancef) Track and communicate progress of team assignments and milestonesg) Demonstrate mastery of the company's policies for CSV, and SDLC and act as a Subject Matter Expert