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.

Sebbene l'esperienza professionale e le qualifiche siano fondamentali per questo ruolo, si assicuri di verificare di possedere le soft skill preferenziali, se richieste, prima di candidarsi.
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

The 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.
Travel 30-50% mainly in Europe.
5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits.
Experienced in the conduct of clinical trial Investigator site audits.
Experience in the conduct of clinical study report/data management clinical trial audits is preferred.
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.
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 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 € 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.
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. xysqume 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.

#J-18808-Ljbffr

Senior QA Auditor - GCP Audits

Autista Ce cqc

Macellaio

Ricevi nuove offerte di lavoro

Macellaio

Badante