QA Auditor 2 (clinical research, home-based)

IQVIA; Reading; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading global provider in life sciences is seeking a Quality Assurance Specialist to manage quality issues and support audit response activities. The ideal candidate will have 3+ years of experience in a related area, strong interpersonal and organizational skills, and the ability to work independently. This role involves evaluating audit findings, managing quality issues, and providing consultancy on compliance procedures.

Qualifications

• 3+ years experience in pharmaceutical, technical, or related area including GXP and/or Quality Assurance.
• Knowledge of GXP regulations and auditing techniques.
• Ability to work independently and manage multiple projects.

Responsibilities

• Support audit response activities across countries involved with contracts.
• Evaluate audit findings and prepare responses to operations staff.
• Manage Quality Issues including review and approval of investigations.

Skills

Interpersonal skills

Problem-solving

Organizational skills

Communication

Teamwork

Education

Bachelor's Degree

Tools

Word-processing applications

Spreadsheet applications

Database applications

Job description

Job Overview
Support quality issues management, Customer Audit/Regulatory Inspections report response management, Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plan review, approval, and closure. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promoting and assessing compliance with regulations, guidelines, and corporate policies. Lead/support QA initiatives/projects for quality and process improvements.

Essential Functions
• Support audit response activities across countries involved with IQVIA contracts to assess compliance with applicable regulations, customer requirements, SOPs, and project-specific guidelines.
• Evaluate audit findings and prepare/distribute responses to operations staff and management.
• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies.
• Manage Quality Issues including reviewing and approving investigations, Root Cause Analysis (RCA), CAPA, and EC plans. Track until closure for quality events arising from QA activities.
• Present educational programs and guidance on compliance procedures to operational staff.
• Provide quality assurance consultancy activities and projects within budget and timelines.
• Evaluate policies and procedures for compliance and recommend continuous improvements.
• Assist in training new QA staff.
• Support QA initiatives/projects for quality and process improvements.
• Manage quality events updates in eQMS and maintain the electronic quality management system.

Qualifications
• Bachelor's Degree preferred.
• 3+ years experience in pharmaceutical, technical, or related area including GXP and/or Quality Assurance. Equivalent education, training, and experience considered.
• Knowledge of word-processing, spreadsheet, and database applications.
• Extensive knowledge of GXP regulations and auditing techniques.
• Strong interpersonal, problem-solving, organizational, communication, and team skills.
• Ability to work independently, manage multiple projects, and establish effective relationships.

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IQVIA is a leading global provider of analytics, technology, and clinical research services to the life sciences industry. We aim to push the boundaries of human and data science to create a healthier world. Learn more at