Job Description

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 documentation.

Assist with maintaining the Regulatory Inspection Library and the continued enhancement of the inspection process. Assist with the development of tools to support inspection execution.

Work collaboratively with all departments to assess, investigate, and manage potential serious breaches of GCP as reported in the QMS.

Ensure responses for regulatory inspections and inquiries, ISO audit responses, and external audit responses (when requested) meet Clario, regulatory, and industry standards.

This remote-based position may require infrequent visits to company offices or other locations to attend meetings or inspection support activities.

OTHER DUTIES AND RESPONSIBILITIES:

1. Manage Issue Review Meetings as part of the Continuous Improvement Process and CAPA management.

2. Provide consulting services to contracted external sources as required.

3. Other related duties and projects as assigned.

The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. CLARIO reserves the right to amend or change this job description to meet the needs of CLARIO. This job description and any attachments do not constitute or represent a contract.