Inspections Compliance Analyst – GxP
The Inspections Compliance Analyst - GxP coordinates and manages assigned Quality Management regulatory inspection and audit activities and supports management and evaluation of identified potential regulatory concerns per the Quality Management System’s (QMS) activities to ensure corporate compliance with regulatory authorities and industry expectations. ESSENTIAL DUTIES AND RESPONSIBILITIES: Under the supervision of the Manager Inspections Compliance - GxP, support the execution of regulatory inspection and audit activities of all regions to include coordination of resources, data, or documents. Promote the Continuous Improvement program through management of issues to ensure accurate root cause analysis, corrective/preventive action implementation and confirmation of effectiveness. Assist with the hosting and management of regulatory inspections for both CLARIO and CLARIO clients. Analyze observations identified and generate effective responses. Maintain associated QM system documen