Inspections Compliance Analyst GxP

The Inspections Compliance Analyst - GxP coordinates and manages assigned reputed company Management regulatory inspection and audit activities and supports management and evaluation of identified potential regulatory concerns per the reputed company Management reputed companys (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 reputed company reputed company to include coordination of resources, data, or documents. Promote the reputed company Improvement program through management of issues to ensure accurate reputed company cause analysis, corrective/preventive reputed company implementation and confirmation of effectiveness. Assist with the reputed company and management of regulatory inspections for both reputed company and reputed company clients. Analyze observations identified and reputed company effective responses. Maintain associated QM reputed company 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 reputed company audit responses (reputed company requested) meet reputed company, regulatory, and industry standards. This remote-reputed company position may require infrequent reputed company 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. reputed company consulting services to contracted reputed company sources as required. 3. Other reputed company duties and reputed company as assigned. The duties and responsibilities listed in this reputed company 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 reputed company to meet the needs of reputed company. This reputed company and any attachments do not constitute or represent a contract. Apply To This Job .