Sr. QA Auditor, GCP

Join to apply for the Sr. QA Auditor, GCP role at IQVIA 1 day ago Be among the first 25 applicants Job Overview Plan and conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. 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 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 Host audits/inspections Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections May perform GLP Archivist duties where needed 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 Qualifications Ability to travel 15-20% across Europe 10 years experience in pharmaceutical, technical, or related area, of which 5 years in Quality Assurance. GCP audit experience is a must. 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. 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. This role is not eligible for UK Visa sponsorship. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com Seniority level Mid-Senior level Employment type Full-time Job function Quality Assurance Industries Hospitals and Health Care Referrals increase your chances of interviewing at IQVIA by 2x #J-18808-Ljbffr