celerion - Quality Assurance Auditor, DMB, UK Based
Upload My Resume
Drop here or click to browse · Tap to choose · PDF, DOCX, DOC, RTF, TXT
Requirements
• Bachelor’s degree in science, IT, business, or similar • 2-5 years of quality/laboratory/clinical experience • Excellent oral and written communication skills • Ability to organize and manage multiple priorities • Attention to detail, tactful, and diplomatic • Proficiency in using electronic data and computerized systems. • Ability to travel, as needed
Responsibilities
• Carry out auditing of study, project, and process reports, records and data; report audit findings to operations via QA audit reports; and determine acceptability of the responses and verify the corrections (includes but not limited to Clinical Study Report audits, Protocol audits and Electronic Database Capture (EDC) audits). • Interact with internal and external clients to discuss QA observations and study-related issues; and maintain effective and professional working relationships within and across departments in relation to study projects. • Participate and lead in the improvement initiatives intended to improve quality, compliance of study, project data and reports; effectiveness and efficiency of the processes. • Detect quality issues and the need for CAPAs and evaluate deviations • Assist with the preparation for and hosting of client audits and/or regulatory inspections. • Participate in the preparation, conduct and follow-up for System Audits and Vendor Audits
No credit card. Takes 10 seconds.