Senior R&D QA GCP Auditor

Senior R&D QA GCP Auditor

Manchester Full-Time 48000 - 84000 £ / year (est.) Home office (partial)
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At a Glance

  • Tasks: Lead audits and ensure compliance in clinical development projects.
  • Company: Join a dynamic social network focused on global health advancements.
  • Benefits: Enjoy flexible working options and a vibrant company culture.
  • Why this job: Make a real impact in clinical trials while developing your skills in a supportive environment.
  • Qualifications: Experience in GCP ICH E6 and clinical trial management is essential.
  • Other info: Opportunities for travel across the UK and Europe.

The predicted salary is between 48000 - 84000 £ per year.

Support the compliance and implementation of GCP and GCLP across the clinical development of global projects.

Audit management from start to finish, from agenda to report.

Conduct mock inspections and audits internally and externally, virtually and onsite.

Support the department to analyse the findings of audits and manage accordingly.

Maintain the annual audit programme of auditing activities.

You:

  • Demonstrable experience in GCP ICH E6 and knowledge of clinical development phases alongside the management of IMPs within clinical trials.
  • Vast experience of completing GCP audits across multiple sites within the UK.
  • Familiar with Trackwise or similar electronic systems alongside frequently auditing electronic medical records.
  • Superior management skills relating to leadership, organisation, decision making and communication.
  • Ability to travel within the UK and Europe.

Senior R&D QA GCP Auditor employer: Carrot Recruitment

As a Senior R&D QA GCP Auditor, you will thrive in a dynamic and supportive work environment that prioritises compliance and innovation in clinical development. Our company offers exceptional employee growth opportunities, a collaborative culture, and the chance to work on global projects that make a real impact in healthcare. Located in the UK, we provide a flexible work-life balance and access to cutting-edge resources, ensuring that you can excel in your role while contributing to meaningful advancements in clinical trials.
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Contact Detail:

Carrot Recruitment Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Senior R&D QA GCP Auditor

✨Tip Number 1

Familiarise yourself with the latest GCP and GCLP guidelines. Understanding these regulations inside out will not only help you in interviews but also demonstrate your commitment to compliance in clinical development.

✨Tip Number 2

Network with professionals in the field of clinical trials and audits. Attend relevant conferences or webinars to connect with others who may have insights into the role and can provide valuable advice or referrals.

✨Tip Number 3

Prepare for potential scenario-based questions during interviews. Think about past experiences where you've successfully managed audits or addressed compliance issues, as these examples will showcase your expertise.

✨Tip Number 4

Stay updated on the latest technologies used in audit management, such as Trackwise. Being knowledgeable about these tools can set you apart from other candidates and show that you're ready to hit the ground running.

We think you need these skills to ace Senior R&D QA GCP Auditor

Knowledge of GCP and GCLP regulations
Experience in conducting GCP audits
Familiarity with ICH E6 guidelines
Understanding of clinical development phases
Management of Investigational Medicinal Products (IMPs)
Audit management skills
Proficiency in Trackwise or similar electronic systems
Experience with electronic medical records auditing
Strong leadership skills
Excellent organisational skills
Effective decision-making abilities
Strong communication skills
Ability to conduct mock inspections
Analytical skills for audit findings
Willingness to travel within the UK and Europe

Some tips for your application 🫡

Understand the Role: Before applying, make sure you fully understand the responsibilities of a Senior R&D QA GCP Auditor. Familiarise yourself with GCP and GCLP guidelines, as well as the clinical development phases mentioned in the job description.

Tailor Your CV: Highlight your demonstrable experience in GCP ICH E6 and your familiarity with auditing processes. Be specific about your past roles, especially those involving audit management and your experience with electronic systems like Trackwise.

Craft a Strong Cover Letter: In your cover letter, emphasise your leadership and communication skills. Provide examples of how you've successfully managed audits and addressed findings in previous roles. Make it clear why you're a great fit for this position.

Proofread Your Application: Before submitting, carefully proofread your CV and cover letter. Look for any spelling or grammatical errors, and ensure that all information is accurate and relevant to the job description.

How to prepare for a job interview at Carrot Recruitment

✨Showcase Your GCP Knowledge

Make sure to brush up on your knowledge of Good Clinical Practice (GCP) and ICH E6 guidelines. Be prepared to discuss how you've applied these principles in previous roles, especially in relation to clinical development phases and managing Investigational Medicinal Products (IMPs).

✨Demonstrate Audit Experience

Highlight your experience with conducting GCP audits across multiple sites. Be ready to share specific examples of audits you've managed, including any challenges you faced and how you overcame them. This will show your practical understanding of the audit process.

✨Familiarity with Electronic Systems

If you have experience with Trackwise or similar electronic systems, make sure to mention it. Discuss how you've used these tools to streamline audit processes or manage electronic medical records, as this is a key requirement for the role.

✨Emphasise Leadership and Communication Skills

Since the role requires superior management skills, be prepared to discuss your leadership style and how you communicate effectively with teams. Share examples of how you've led projects or initiatives, particularly in high-pressure situations, to demonstrate your decision-making abilities.

Senior R&D QA GCP Auditor
Carrot Recruitment
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  • Senior R&D QA GCP Auditor

    Manchester
    Full-Time
    48000 - 84000 £ / year (est.)

    Application deadline: 2027-06-26

  • C

    Carrot Recruitment

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