Clinical Trials Quality Assurance (Senior) Auditor - UK/EU - CAPA Management
Review & approve investigations, Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA) and Effectiveness Check (EC) plans and track till closure for medium/high-risk/complex quality events arising from Quality Issues, Audits, Inspections or during similar QA activities. Perform Quality Event management within QA-CAPA Center Of Excellence, responsible for processing/supporting:
- Customer audits and regulatory inspections
- Quality issue and query escalations to QA
Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.
Essential Functions as applicable and/or required:
• Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts 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
• Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans
• Manage Quality Issues
• Present educational programs and provide guidance to operational staff on compliance procedures
• Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closures for quality events arising from Quality Issues, Audits, Inspections or during similar QA activities
• Provide quality assurance consultancy activities and projects for clients within budget and established timelines
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
• Manage/oversee quality events updates in eQMS and/or 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
• Bachelor's Degree Pref
• 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance. GCP and Clinical Trial experience. Equivalent combination of education, training and experience.
• Knowledge of word-processing, spreadsheet, and database applications..
• Extensive knowledge of pharmaceutical/Clinical 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. Learn more at https://jobs.iqvia.com