QA Auditor II

IQVIA Holdings Inc.

Reading, Berkshire, United Kingdom

The IQVIA Enterprise QA team is a dynamic, talented, and experienced global team that owns the global Quality Management System for the Largest Human Data Science Company in the world. The QA function is responsible for driving compliance in a highly regulated industry through audits, functional support, issue & CAPA management, regulatory consultancy, management of data analytics and customer relationship interactions. These services ensure our clinical research activities are of the highest quality. We proactively support our business partners and help to drive innovation. Continuous improvement is a core capability, and we value strategic thinking, creativity and operational excellence.

We seek highly motivated people who truly want to make a difference in the life sciences industry and are looking for opportunities to impact the business and be part of the solution. At IQVIA, we support our colleagues with a focus on succession planning, career progression and continuous learning.

Purpose:

The QA Auditor 2 will 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:• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures• Provide consultation to internal stakeholders 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• 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 staffQualifications:• Bachelor's Degree • 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance. GCP experience. Equivalent combination of education, training and experience.• 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 internal stakeholders