Senior Clinical Auditor

hace 1 mes

Madrid, Madrid, España IQVIA A tiempo completo
Job Overview

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We are seeking a highly skilled and experienced Senior Clinical Auditor to join our team.

Key Responsibilities
  • 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.
  • Maintains the electronic quality management system (eQMS) and provides 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.
Requirements
  • Bachelor's Degree preferred.
  • 5 years 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.

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