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- Tasks: Conduct GCP audits and ensure compliance across clinical sites and vendors.
- Company: Join Advarra, a leading company in clinical research with a collaborative culture.
- Benefits: Flexible freelance role with opportunities to make a real impact in healthcare.
- Other info: Work remotely and enjoy a supportive environment that values your contributions.
- Why this job: Empower patients and enhance clinical research while working with diverse teams.
- Qualifications: 10+ years in Clinical Quality Assurance and strong auditing experience required.
The predicted salary is between 60000 - 80000 £ per year.
At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each person is not only valued but empowered to thrive and make a meaningful impact.
Location
This role is open to candidates based in the United Kingdom.
Company Culture
Our people—both employees and consultants—are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.
Job Overview Summary
Advarra is seeking Good Clinical Practice (GCP) Auditors to join our consultant network for United Kingdom‑based projects. Auditors support compliance reviews across GCP clinical sites and vendors.
Job Duties & Responsibilities
- Conduct Good Clinical Practice (GCP) audits (planning, agenda, physical or remote audit, and report writing).
- Evaluate investigator sites, CROs, and vendor compliance or qualification.
- Prepare comprehensive audit reports detailing findings and root-causes.
- Provide written audit reports in English.
- Provide corrective actions support and present findings to QA leadership and stakeholders if required.
- Work collaboratively with clients to ensure quality standards.
Basic Qualifications
- Minimum 10+ years of Clinical Quality Assurance and/or Good Clinical Practice (GCP) experience.
- Minimum 5+ years of Good Clinical Practices auditing experience.
- Demonstrated experience with regulatory agency expectations (e.g., FDA, EMA) and audit readiness activities.
- Demonstrated experience in developing and implementing quality assurance plans, audit programs, and corrective action plans.
- B2 level in English communication, verbal and written.
- Bachelor's degree.
Preferred Qualifications
- Strong interpersonal and client interaction skills.
- Excellent analytical, problem‑solving, communication, and report‑writing skills.
- Ability to work collaboratively across departments and interact with internal and external stakeholders.
Pharmaceutical Quality GCP Auditors Freelance/Independent (Consulting) employer: Advarra
Contact Detail:
Advarra Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Pharmaceutical Quality GCP Auditors Freelance/Independent (Consulting)
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry and let them know you're on the lookout for GCP auditing gigs. You never know who might have a lead or can put in a good word for you.
✨Tip Number 2
Show off your expertise! When you get the chance to chat with potential clients or during interviews, highlight your 10+ years of Clinical Quality Assurance experience. Make sure they know you’re the go-to person for GCP audits.
✨Tip Number 3
Be proactive! If you see a project that interests you on our website, don’t hesitate to apply. Tailor your approach to showcase how your skills align with Advarra’s values of being patient-centric and quality-focused.
✨Tip Number 4
Prepare for those interviews! Brush up on your knowledge of regulatory agency expectations and audit readiness activities. Being well-prepared will show that you’re serious about making a meaningful impact in clinical research.
We think you need these skills to ace Pharmaceutical Quality GCP Auditors Freelance/Independent (Consulting)
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the GCP Auditor role. Highlight your relevant experience in Clinical Quality Assurance and Good Clinical Practice, as well as any specific projects that align with our values at Advarra.
Showcase Your Skills: Don’t just list your qualifications; demonstrate how your skills in audit planning, report writing, and compliance reviews can contribute to our mission. Use examples that reflect your analytical and problem-solving abilities.
Be Clear and Concise: When writing your application, keep it straightforward and to the point. We appreciate clarity, so make sure your key achievements and experiences stand out without unnecessary fluff.
Apply Through Our Website: We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it shows you’re keen on joining our collaborative culture!
How to prepare for a job interview at Advarra
✨Know Your GCP Inside Out
Make sure you brush up on Good Clinical Practice (GCP) guidelines and any recent updates. Being able to discuss specific regulations and how they apply to the role will show your expertise and commitment to quality.
✨Showcase Your Experience
Prepare to share detailed examples from your 10+ years in Clinical Quality Assurance. Highlight specific audits you've conducted, challenges you've faced, and how you ensured compliance. This will demonstrate your hands-on experience and problem-solving skills.
✨Emphasise Collaboration
Since Advarra values a collaborative environment, be ready to discuss how you've worked with clients and stakeholders in the past. Share instances where teamwork led to successful audit outcomes or improved quality standards.
✨Communicate Clearly
With a B2 level in English required, practice articulating your thoughts clearly and concisely. Prepare to present your audit findings as if you're speaking to QA leadership, ensuring you can convey complex information in an understandable way.