Are you a Computer Systems Validation expert with knowledge of ERP systems?
SQA is working with a growing pharmaceutical company to support their Computer Systems Validation efforts. They have an immediate need for a Quality and Compliance specialist to oversee quality, compliance and governance of multiple Computer System Validation (CSV) projects, working against SOP’s, SLC and FDA regulatory guidelines. Working directly with multiple business units, this resource will review and approve all validation documentation and oversee the execution of validation protocols for all GxP-impacted systems. The CSV specialist will provide guidance to project teams during the planning and definition phases to develop a validation approach commensurate to the risk level assigned to the systems. Subsequently, they will coordinate investigations into failures to meet acceptance criteria and determine appropriate corrective actions.