Senior QA Auditor

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 simillar 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 QA staff

Qualifications

Bachelor's Degree in a relevant specialisation.

5 years' experience in Pharmaceutical or Pharmaceutical Manufacturing or Medical Device or Quality Assurance in a highly regulated environment.

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 player 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 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.