Huidige banen gerelateerd aan Clinical Auditor - Amsterdam, Noord-Holland - IQVIA

We are seeking a highly skilled Clinical Auditor to join our team at IQVIA. As a Clinical Auditor, you will be responsible for planning and conducting independent clinical audits to assess compliance with regulations, guidelines, and operating procedures.

• Plan, schedule, conduct, report, and close audit activities to assess compliance with applicable regulations, guidelines, customer requirements, IQVIA SOPs, and project-specific guidelines/instructions.
• Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
• Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA), and Effectiveness Check (EC) plans and track till closure for quality events arising from Audits; and from Quality Issues, Inspections, or during similar QA activities as assigned.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
• Maintain the electronic quality management system (eQMS) and provide support in relation to the audit lifecycle.
• Lead/collaborate/support in QA initiatives/projects for quality, process improvements.
• Assist in training of new Quality Assurance staff.
• May be required to manage Quality Issues.
• May present educational programs and provide guidance to operational staff on compliance procedures.
• May host audits/inspections; ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections, as assigned.

• Bachelor's Degree preferred.
• 5 years of experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits. GCP experience. Equivalent combination of education, training, and experience.
• Experienced in the conduct of CSR/DM/BIOS clinical trial audits.
• Knowledge of word-processing, spreadsheet, and database applications.
• Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
• Knowledge of quality assurance processes and procedures.
• Strong interpersonal skills.
• Excellent problem-solving, risk analysis, and negotiation skills.
• Strong training capabilities.
• Effective organization, communication, and team orientation skills.
• Ability to initiate assigned tasks and to work independently.
• Ability to manage multiple projects.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.