Inspections Compliance Analyst – GxP

Shanghai, ChinaRemote

Responsibilities

Promote the Continuous Improvement program through management of issues to ensure accurate root cause analysis, corrective/preventive action implementation and confirmation of effectiveness.
Analyze observations identified and generate effective responses.
Maintain associated QM system documentation.
Ensure responses for regulatory inspections and inquiries, ISO audit responses, and external audit responses (when requested) meet Clario, regulatory, and industry standards.
Manage Issue Review Meetings as part of the Continuous Improvement Process and CAPA management. 2.
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.

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

Clario, part of Thermo Fisher Scientific is hiring a Inspections Compliance Analyst - GxP that 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.
Assist with the hosting and management of regulatory inspections for both CLARIO and CLARIO clients.
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.
This remote-based position may require infrequent visits to company offices or other locations to attend meetings or inspection support activities. OTHER DUTIES AND
Provide consulting services to contracted external sources as required. 3.
Other related duties and projects as assigned. The duties and