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- Tasks: Conduct independent audits in global clinical research and ensure compliance with regulations.
- Company: Renowned international QA consultancy in the life sciences sector.
- Benefits: Competitive salary, fully remote work, flexible hours, and professional development opportunities.
- Why this job: Join a respected consultancy and make a real impact in clinical quality assurance.
- Qualifications: 5+ years of GCP auditing experience and strong communication skills.
- Other info: Opportunity for international travel and exposure to diverse global clients.
Salary: £60,000 per annum
Contract: Permanent
Location: Fully Remote (occasional travel for audits)
Sector: Quality Assurance / Clinical Research
About the Company
Our client is an international QA consultancy renowned for delivering expert GxP auditing services across the life sciences sector. Partnering with leading pharmaceutical, biotechnology, and CRO organisations, they provide trusted, independent auditing solutions across GCP, GLP, and GDP. Due to continued global growth, they are seeking an experienced GCP Auditor to join their expanding team.
The Role
As a GCP Auditor, you’ll play a key role in conducting independent audits across global clinical research operations. Working remotely, you’ll plan, perform, and report on approximately two audits per month, covering investigator sites, vendors, and internal systems. You’ll collaborate with clients to ensure compliance with ICH GCP and applicable regulatory requirements, offering expert guidance and insight.
Key Responsibilities
- Plan, schedule, and conduct GCP audits (investigator site, vendor, system, and internal process).
- Prepare detailed audit reports and communicate findings effectively to clients.
- Advise on CAPA development and follow-up to ensure timely closure of audit findings.
- Support inspection readiness and client training initiatives as needed.
- Stay current with global GCP regulations and guidance documents.
Requirements
- Minimum 5 years’ experience conducting GCP audits independently.
- Proven background in QA within the pharmaceutical, biotech, or CRO environment.
- Strong understanding of ICH GCP, EU, and FDA regulations.
- Excellent communication and reporting skills.
- Ability to manage time effectively and work autonomously in a remote setting.
- Willingness to travel internationally for scheduled audits (typically 2 per month).
What’s on Offer
- Competitive £60,000 salary (plus expenses).
- Fully remote role with flexible working.
- Opportunity to work with an established international consultancy.
- Professional development and exposure to a wide range of global clients and studies.
Interested? If you’re an experienced GCP Auditor looking to join a respected international consultancy where your expertise truly adds value, we’d love to hear from you. Apply now or contact us for a confidential discussion.
Clinical Quality Assurance Auditor employer: Qualitas
Contact Detail:
Qualitas Recruiting Team
We think you need these skills to ace Clinical Quality Assurance Auditor
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the GCP Auditor role. Highlight your relevant experience in QA and GCP audits, and don’t forget to mention any specific regulations you’re familiar with. We want to see how your background aligns with what we’re looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality assurance and how your skills can benefit our team. Keep it concise but impactful – we love a good story that showcases your expertise.
Showcase Your Communication Skills: As a GCP Auditor, communication is key. In your application, demonstrate your ability to convey complex information clearly. Whether it’s through your CV or cover letter, we want to see examples of how you’ve effectively communicated findings in the past.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about our company and culture!
How to prepare for a job interview at Qualitas
✨Know Your GCP Inside Out
Make sure you brush up on your knowledge of ICH GCP, EU, and FDA regulations. Being able to discuss these confidently will show that you're not just familiar with the standards but can also apply them in real-world scenarios.
✨Prepare for Scenario-Based Questions
Expect questions that ask how you would handle specific audit situations. Think about past experiences where you had to advise on CAPA development or manage audit findings, and be ready to share those examples.
✨Showcase Your Communication Skills
As a GCP Auditor, you'll need to communicate findings effectively. Practice explaining complex concepts in simple terms, as this will demonstrate your ability to convey important information to clients clearly.
✨Demonstrate Your Autonomy
Since this role is remote, highlight your ability to work independently. Share examples of how you've successfully managed your time and completed audits without direct supervision, showcasing your self-motivation and organisational skills.