Senior QA Auditor - GCP Audits

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7otvrn

ppPlan 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. /ph3Essential Functions /h3ulliPlan, 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 /liliEvaluate audit findings and prepare and distribute reports to operations staff, management, and customers /liliProvide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures /liliProvide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans /liliReview, 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. /liliEvaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements /liliMaintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle /liliLead/collaborate/support in QA initiatives/projects for quality,



process improvements /liliAssist in training of new Quality Assurance staff /liliMay be required to manage Quality Issues /liliMay present educational programs and provide guidance to operational staff on compliance procedures /liliMay 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. /li /ulh3Qualifications /h3ulliThe right candidate must be Certified to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 Nov 2011. /liliTravel 30-50% mainly in Europe. /lili5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits. /liliExperienced in the conduct of clinical trial Investigator site audits. /liliExperience in the conduct of clinical study report/data management clinical trial audits is preferred. /liliKnowledge of word-processing, spreadsheet, and database applications. /liliExtensive knowledge of pharmaceutical research and development processes and regulatory environments. /liliKnowledge of quality assurance processes and procedures. /liliStrong interpersonal skills. /liliExcellent problem solving, risk analysis and negotiation skills. /liliStrong training capabilities. /liliEffective organization, communication, and team orientation skills. /liliAbility to initiate assigned tasks and to work independently. /liliAbility to manage multiple projects. /liliAbility to establish and maintain effective working relationships with coworkers, managers and clients. /li /ulpIQVIA 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. /ppLearn more at /ppIQVIA 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. /ppThe potential base pay range for this role, when annualized, is € 47.500,00 - € 71.300,00. 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 tempo parziale). 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. /ppIQVIA 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. /ppThank you for your interest in growing your career with us. /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7otvrn