Position requires a Masters degree, or foreign equivalent in Regulatory Affairs, Pharmaceutical Sciences, or a related field plus 3 years experience performing quality assurance activities in a GMP environment for therapeutics research and development.br In the alternative, employer will accept a Bachelors degree, or foreign equivalent, in Regulatory Affairs, Pharmaceutical Sciences, or a related field plus 5 years experience performing quality assurance activities in a GMP environment for therapeutics research and development.br br The position also requires experience in the following, which may be gained concurrentlybr 1 year experience as administrator for Veeva Vault document and quality systems management QMS software modules;br 1 year experience in software validation, including but not limited to creating change controls, test plans, and executing test plans;br 1 year experience in maintaining on and offsite paper records and data including reviewing, scanning, and archiving so that they are retrievable and readable for their defined retention period;br Training as ComplianceWire administrator for GXP as demonstrated by Certificate of executed ComplianceWire Organization Administrator workshop provided by UL for any of the 3 mentioned courses ComplianceWire Security Roles, ComplianceWire Curriculum Creation and Versioning, Reporting for Audits, Control Documents and Using Quizzes, The Value of Custom Fields, ComplianceWire Assignment Best Practices, ComplianceWire Working with ILT Courses, ComplianceWire Reporting Basics, ComplianceWire Custom Exams, ComplianceWire Data Upload Tools, ComplianceWire Basic Site Configuration Options.br Required ComplianceWire Certificate may be provided through workshop, not over a period of months, thus responded quot;noquot; to question H.5 as it is not applicable

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