GLP/GCP Quality Compliance Auditor
仕事内容
Lead and manage the internal audit program to ensure GLP/GCP compliance and alignment with ISO 15189/13485 standards, while maintaining regulatory inspection readiness.
Plan audit scopes, schedule audits, and assign tasks to appropriate team members, coordinating with cross-functional stakeholders.
Serve as the primary host for internal audits and provide regulatory inspection support as required.
Document audit findings and develop actionable CAPAs, monitoring their effectiveness and guiding management through audit review meetings.
Develop and coach internal auditors through training and mentorship, while collaborating with QA management on regulatory updates and staff education.
Drive continuous improvement in audit processes using risk-based methodologies to uphold quality across laboratory testing operations.
Plan audit scopes, schedule audits, and assign tasks to appropriate team members, coordinating with cross-functional stakeholders.
Serve as the primary host for internal audits and provide regulatory inspection support as required.
Document audit findings and develop actionable CAPAs, monitoring their effectiveness and guiding management through audit review meetings.
Develop and coach internal auditors through training and mentorship, while collaborating with QA management on regulatory updates and staff education.
Drive continuous improvement in audit processes using risk-based methodologies to uphold quality across laboratory testing operations.
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