Job Description

Remote Opportunity

Summary:

The Work we do at IQVIA impacts lives all over the world. At IQVIA, the Largest Human Data Science Company in the world, we accelerate innovation for a healthier world. Come and join us to help our customers and partners do extraordinary things for healthcare!

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.

The workplace is remote and located in Canada or USA. The travel requirement is about 20-40%.

Purpose:

The QA Auditor 2 will conduct and/or support vendor audits and report preparation/distribution, Support quality issues management, Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plan review, approval and closure and Vendor Audit plan development. Expertise in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies, lead/support in QA initiatives/projects for quality, process improvements.

Summary of Responsibilities:

Conducts quality assurance audits of vendors delivering GXP services (GCP, GLP, GMP) within budget and established timelines by scheduling, conducting, reporting, and closing audits as directed by the lead auditor. Activities may include contacting auditees to agree on audit dates, making appropriate entries in the eQMS, filling out audit report forms, performing data reviews, file audits as directed.

Enters and categorizes audit/Inspection findings in the eQMS,

Solicits follow-up information and closing audits/inspection findings in the eQMS.

Reviews and approval of Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plans

Reviews vendor documents, identifying and calling vendor staff to answer related questions.

Demonstrates a fundamental knowledge of current relevant GXP regulations (GCP/GLP/GMP), guidelines, and related auditing techniques.

Performs required administrative duties including tracking of documents reviewed, scheduling vendor team members for interviews.

Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle.

Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.

Assist in training of new Quality Assurance staff.

Support in QA initiatives/projects for quality, process improvements

Manage/oversee quality events updates in eQMS

Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle

Required Education and Experience:

3 years experience in Quality Assurance in pharmaceutical, CRO, biotech, technical, or related area including Quality Assurance experience

GXP experience

Bachelor's degree in a scientific or healthcare-related field

Required Knowledge, Skills and Abilities:

Knowledge of word-processing, spreadsheet, and database applications.

Considerable knowledge of GXP regulations and quality assurance auditing techniques.

Strong interpersonal skills.. Excellent problem solving skills.

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.

Required Travel:

20-40%

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at