Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Conduct audits to ensure compliance with GCP and GCLP in clinical research.
- Company: Join a privately-owned company committed to ethical research in healthcare.
- Benefits: Enjoy a competitive salary, bonuses, and a supportive work environment.
- Why this job: Be part of impactful projects in diverse therapeutic areas while promoting ethical practices.
- Qualifications: Experience as a GCP-GCLP auditor or in clinical trials management is essential.
- Other info: Full-time position with opportunities for professional growth and development.
The predicted salary is between 43200 - 72000 £ per year.
About the role
Our client is a privately-owned company that allows them the freedom to decide which research they invest in. They have a strong code of ethics and conduct and are committed to ethical and social responsibility. They have medicines within Cardiovascular, Neonatal, Transplantation, Respiratory, and have an exciting specialty pipeline.
Your role will be to ensure compliance with the correct application of Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) in the clinical development of Global R&D projects in UK and EU environments.
Key Responsibilities
- Execution of first-party audits and mock inspections inside Global R&D departments.
- Execution of second-party audits (remote and on-site) to Contract Research Organizations (CRO), clinical laboratories, Trial Master Files, investigational sites, and clinical service providers supporting clinical trials under UK and EU requirements.
- Management of the audit process from the agenda to the finalization of audit reports.
- Support Global R&D Departments and Global R&D QA Auditing & Supplier Qualification Unit in managing findings (non-conformities) from audits.
- Assist the Unit Head in collecting information for the preparation of the annual audit programme for GCP and GCLP auditing activities.
- Support the monitoring and updating of the annual audit programme for GCP and GCLP auditing activities.
- Finalization/review of SOPs relating to GCP-GCLP auditing activities.
- Organization of training on GCP-GCLP regulations/procedures under UK and EU requirements.
Candidate Profile
- Experience as a GCP-GCLP auditor in a pharmaceutical company or Contract Research Organization (CRO).
- Clinical trials management experience on investigational medicinal products as a Clinical Research Associate (CRA) or Clinical Project Manager (CPM) in a pharmaceutical company or CRO.
- Knowledge of GCP-GCLP requisites under UK and EU requirements.
- Knowledge of auditing techniques.
- Knowledge of training techniques.
- Knowledge of the pharmaceutical development process, specifically the clinical development phases and management of investigational medicinal products in clinical trials.
- Proficiency with principal informatic systems (Word, Excel, Outlook, PowerPoint) and Trackwise for managing audits and findings (non-conformities) from audits and the management of clinical service providers.
An excellent salary and benefits package will be offered.
Please apply online or contact CHASE for further information on 0131 553 6644.
Senior R&D QA GCP Auditor - UK employer: Chase Recruitment Limited
Contact Detail:
Chase Recruitment Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior R&D QA GCP Auditor - UK
✨Tip Number 1
Network with professionals in the pharmaceutical and clinical research fields. Attend industry conferences or webinars where you can meet GCP-GCLP auditors and learn about their experiences. This can provide valuable insights and potentially lead to referrals.
✨Tip Number 2
Stay updated on the latest GCP and GCLP regulations and guidelines. Follow relevant organisations and publications to ensure you are aware of any changes that could impact your role. This knowledge will not only help you in interviews but also demonstrate your commitment to the field.
✨Tip Number 3
Prepare for potential interview questions by reviewing common scenarios faced by GCP-GCLP auditors. Think about how you would handle specific audit situations or non-conformities, as this will showcase your problem-solving skills and practical experience.
✨Tip Number 4
Familiarise yourself with the company’s values and ethical standards. Since the client emphasises a strong code of ethics, be ready to discuss how your personal values align with theirs during the interview process. This alignment can set you apart from other candidates.
We think you need these skills to ace Senior R&D QA GCP Auditor - UK
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience as a GCP-GCLP auditor or in clinical trials management. Use specific examples that demonstrate your knowledge of GCP-GCLP requisites and auditing techniques.
Craft a Strong Cover Letter: Write a cover letter that reflects your understanding of the company's commitment to ethical and social responsibility. Mention how your background aligns with their focus on cardiovascular, neonatal, transplantation, and respiratory medicines.
Highlight Relevant Skills: In your application, emphasise your proficiency with informatic systems like Word, Excel, and Trackwise. Detail your experience in managing audits and findings, as well as your ability to organise training on GCP-GCLP regulations.
Proofread Your Application: Before submitting, carefully proofread your application for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial for a role focused on compliance and auditing.
How to prepare for a job interview at Chase Recruitment Limited
✨Showcase Your GCP-GCLP Knowledge
Make sure to brush up on your knowledge of Good Clinical Practice and Good Clinical Laboratory Practice. Be prepared to discuss specific examples from your past experience where you ensured compliance with these standards.
✨Demonstrate Audit Experience
Highlight your experience in conducting audits, both first-party and second-party. Be ready to explain your approach to managing the audit process and how you've handled findings in previous roles.
✨Familiarise Yourself with the Company
Research the company’s pipeline and their commitment to ethical practices. Understanding their focus areas, such as cardiovascular and neonatal medicines, will help you align your answers with their values during the interview.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills in real-world situations. Think of examples where you had to manage non-conformities or train others on GCP-GCLP regulations.
