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Plan and conduct independent clinical (GCP) 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 • 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 perform pre-inspection visits at sites, host audits/inspections; ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections, as assigned. Qualifications • Travel 30-50% mainly in Europe. • 5 years of experience in GCP environment of which 3 years in Quality Assurance Site Audit is a must. • Experienced leading clinical trial Investigator site audits is a must. (At least 7-10 per year) • It is a nice to have a certification to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 Nov 2011. • 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. 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 IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is zł 168.100,00 - zł 312.100,00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. 
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Iqvia
Warsaw
Poland, Senior QA Auditor - GCP Audits.
SENIOR LEVELQA
more at Iqvia.
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