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For Companies At a Glance
- Tasks: Conduct GCP audits and prepare clear reports while managing compliance trends.
- Company: Join Nexia, a leader in biotechnology and pharmaceutical manufacturing.
- Benefits: Enjoy remote work flexibility and opportunities for professional growth.
- Why this job: Make an impact in clinical trials while collaborating with diverse teams.
- Qualifications: Degree in Life Sciences or related field; strong GCP auditing experience required.
- Other info: Mid-senior level position with a focus on quality assurance.
The predicted salary is between 20000 - 28000 £ per year.
Direct message the job poster from Nexia
Role Overview
We are seeking a skilled GCP Auditor to ensure our clients\’ clinical trials meet the highest regulatory and quality standards. You will plan, conduct and report on GCP audits across investigator sites, suppliers and internal processes, manage CAPAs, and support inspection readiness activities. This role requires strong GCP knowledge, excellent communication skills and the ability to work independently in a fast-paced environment.
Key Responsibilities
- Conduct GCP audits (site, supplier, internal) and prepare clear, concise reports.
- Manage CAPAs through to closure and track compliance trends.
- Contribute to risk-based audit planning and quality process improvements.
- Support regulatory inspection readiness and participate in inspections.
- Collaborate with cross-functional teams to ensure compliance and best practice.
Requirements
- Degree in Life Sciences, Quality or related field.
- Strong experience in GCP auditing and regulatory compliance.
- Solid understanding of ICH GCP and relevant global regulations.
- Excellent communication, analytical and organisational skills.
- Ability to work independently in a remote setting.
Preferred
- Experience with other GxPs (GCLP, GVP) and global clinical trials.
Seniority level
-
Seniority level
Mid-Senior level
Employment type
-
Employment type
Full-time
Job function
-
Job function
Quality Assurance, Science, and Research
-
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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GCP Auditor employer: Nexia
Contact Detail:
Nexia Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land GCP Auditor
✨Tip Number 1
Familiarise yourself with the latest ICH GCP guidelines and relevant global regulations. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the GCP auditing space. Attend industry conferences or webinars, and connect with people on platforms like LinkedIn. This can lead to valuable insights and potential referrals for the role.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed CAPAs and contributed to audit planning in previous roles. Being able to articulate your experience clearly will set you apart from other candidates.
✨Tip Number 4
Showcase your ability to work independently by sharing experiences where you successfully completed projects or audits without direct supervision. This is crucial for a remote setting like the one offered at Nexia.
We think you need these skills to ace GCP Auditor
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a GCP Auditor. Familiarise yourself with GCP auditing processes, regulatory compliance, and the specific requirements mentioned in the job description.
Tailor Your CV: Customise your CV to highlight relevant experience in GCP auditing and regulatory compliance. Emphasise your degree in Life Sciences or related fields, and any specific projects or roles that demonstrate your expertise.
Craft a Compelling Cover Letter: Write a cover letter that showcases your strong communication skills and ability to work independently. Mention your experience with CAPAs and inspection readiness, and how you can contribute to the company's quality process improvements.
Proofread Your Application: Before submitting, carefully proofread your application materials for any errors or inconsistencies. A well-presented application reflects your attention to detail, which is crucial for a role in quality assurance.
How to prepare for a job interview at Nexia
✨Showcase Your GCP Knowledge
Make sure to brush up on your Good Clinical Practice (GCP) knowledge before the interview. Be prepared to discuss specific regulations and how they apply to clinical trials, as this will demonstrate your expertise and understanding of the role.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about past experiences where you managed CAPAs or conducted audits, and be ready to explain your thought process and the outcomes.
✨Highlight Communication Skills
Since excellent communication is key for this role, prepare examples that showcase your ability to convey complex information clearly. Discuss how you've collaborated with cross-functional teams to ensure compliance and best practices.
✨Demonstrate Independence and Adaptability
This position requires working independently in a fast-paced environment. Share examples of how you've successfully managed your time and priorities in previous roles, especially in remote settings, to show you're a self-starter.
