Senior Quality Assurance Auditor

Sr QA Auditor

JOB OVERVIEW

Job Profile Summary

Provide Quality Assurance support in managing assigned Quality Events in accordance with the IQVIA Process/System requirement. Provide consultation in interpretation of regulations, guidelines, policies, and procedures.  Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies, support in QA initiatives/projects for quality process improvements. 

Responsibilities

Essential Functions

• Review, approve investigations, Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA) and Effectiveness Check (EC) plans and track till closure for Quality Issues and findings.

• 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 electronic quality management system (eQMS) and/or maintain the eQMS and provide support related to the Quality Events lifecycle.

• Provide consultation to internal stakeholders on interpreting audit/inspection observations and formulating CAPA plans.

• Assist in training/Onboarding of new Quality Assurance staff.

• Accurate reporting and documentation of robust CAPAs in the electronic quality management system (eQMS) and adequate tracking of corrective and preventative actions and effectiveness checks for completion within the required timelines.

• Lead/collaborate/support QA initiatives/projects for quality, process/system improvements and departmental goals.

• Perform other work activities as assigned by the Line Manager.

Participate in regular supervision. Attend all mandatory training. Participate annually identifying, developing and agreeing own development plan with Line Manager. Comply with all IQVIA policies, procedures and protocols. Seek advice and support from Line Manager whenever necessary. Maintain professional conduct at all times.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Experience

Typically requires 8+ years of prior relevant experience.

Knowledge

Requires advanced knowledge of QA job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.

Education

Bachelor's Degree

Additional Work Experience

8+ years experience in pharmaceutical, technical, or related area with GXP experience, of which 6 years in Quality Assurance. Equivalent combination of education, training and experience

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.

Experience Level

Senior Level