หน้าที่ความรับผิดชอบ

Conducts internal and/or external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines, and/or client contractual obligations. Identifies and addresses non-conformance issues. Plans and delivers quality services for contracted quality assurance audits, internal site audits, laboratory audits, and file audits for clients and projects. Applies company policies and procedures to resolve routine issues.

Essential Functions:

• Conducts a variety of client, internal or GxP audits and supports regulatory inspections as requested by senior management
• Participates in process audits
• Performs other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, facility audits, process improvement)
• Serves as a resource to operational departments on audit or quality assurance subject matter
• Prepares and presents audit findings and/or other related information at departmental, internal operations or client meetings