Bachelor’s Engineering Degree preferred
- Minimum of 3 years’ relevant quality work experience.
- Experience in risk-based validation of configured-COTS and custom software systems.
- Good understanding of supply chain system operation.
- Proficient in Visual ERP workflows and operations to support FDA / ISO regulated activities.
- Working knowledge of Infor Visual Manufacturing ERP system modules: Receiving Inspection, Purchasing, Planning, Inventory, Warehouse, Work Orders, Shipping, etc.
- Proficient in Microsoft Office applications including, but not limited to Word, Excel, Outlook, Visio, PowerPoint, etc.
- Good understanding of 21 CFR Part 820, 21 CFR Part 11, ISO 13485, ISO 14971, GAMP 5, Good Documentation Practices (GDP).
- Understanding of SQL Server database concepts.
- Works independently and contributes to the validation of the ERP system
This position supports the validation of Visual Manufacturing ERP system so that it is compliant with internal company procedures, applicable industry standards and regulations. This resource will work in a regulated environment to support GxP operations for Visual ERP software validation. The contractor will work closely with the Business, Subject Matter Experts, IT, Quality and Validation personnel to validate the Visual ERP system. It is imperative that this individual be able to write test scripts for Visual ERP. The contractor will be required to provide their own laptop and be available to work on site for the duration of this assignment.
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