Inspections Compliance Analyst – GxP

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Under the supervision of the Manager Inspections Compliance - GxP, support the execution of regulatory inspection and audit activities of reputed company regions to include coordination of resources, data, or documents.

Promote the reputed company 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 reputed company and reputed company clients. Analyze observations identified and generate effective responses. Maintain associated QM system documentation.

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

Work collaboratively with reputed company 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 (reputed company requested) meet reputed company, 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 reputed company Improvement Process and CAPA management.

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

3. Other reputed company 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. reputed company reserves the right to amend or change this job description to meet the needs of reputed company. This job description and any attachments do not constitute or represent a contract.