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For Companies At a Glance
- Tasks: Support quality management and compliance in clinical research from the comfort of your home.
- Company: Join IQVIA, a global leader in analytics and clinical research services for the life sciences industry.
- Benefits: Enjoy remote work flexibility, competitive pay, and opportunities for professional growth.
- Why this job: Be part of a mission to improve global health while developing your skills in a dynamic environment.
- Qualifications: Bachelor's degree preferred; 3+ years in pharmaceutical or quality assurance roles required.
- Other info: Ideal for self-starters who thrive in a collaborative, innovative culture.
The predicted salary is between 36000 - 60000 £ per year.
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
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QA Auditor 2 (clinical research, home-based) employer: IQVIA
Contact Detail:
IQVIA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Auditor 2 (clinical research, home-based)
✨Tip Number 1
Familiarise yourself with GXP regulations and auditing techniques, as these are crucial for the QA Auditor role. Consider joining relevant online forums or groups where you can discuss these topics with industry professionals.
✨Tip Number 2
Network with current or former QA professionals in clinical research. Reach out on LinkedIn or attend industry events to gain insights into the role and potentially get referrals.
✨Tip Number 3
Prepare to discuss your experience with CAPA and RCA during interviews. Think of specific examples where you've successfully managed quality issues or led initiatives that improved compliance.
✨Tip Number 4
Stay updated on the latest trends and changes in quality assurance within the pharmaceutical industry. Subscribing to relevant journals or newsletters can provide you with valuable information to discuss during your interview.
We think you need these skills to ace QA Auditor 2 (clinical research, home-based)
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities and qualifications required for the QA Auditor 2 position. This will help you tailor your application to highlight relevant experiences.
Tailor Your CV: Customise your CV to reflect your experience in quality assurance, particularly in clinical research or pharmaceutical settings. Emphasise your knowledge of GXP regulations and any relevant auditing techniques you've used.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also demonstrates your understanding of the company's mission and how your skills can contribute to their goals in quality assurance.
Highlight Relevant Experience: In your application, be sure to detail your experience with audit response activities, CAPA processes, and any training or consultancy roles you've held. Use specific examples to illustrate your problem-solving and organisational skills.
How to prepare for a job interview at IQVIA
✨Know Your Regulations
Familiarise yourself with GXP regulations and auditing techniques. Be prepared to discuss how these regulations apply to the role and provide examples of how you've ensured compliance in previous positions.
✨Showcase Your Problem-Solving Skills
Prepare to share specific instances where you've successfully managed quality issues or led corrective actions. Highlight your analytical skills and how you approach root cause analysis.
✨Demonstrate Communication Skills
As a QA Auditor, you'll need to communicate effectively with various teams. Practice articulating complex regulatory concepts in simple terms, and be ready to discuss how you've trained others on compliance procedures.
✨Be Ready for Scenario Questions
Expect scenario-based questions that assess your decision-making and prioritisation skills. Think about past experiences where you had to manage multiple projects or respond to audit findings under pressure.