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- Tasks: Lead and execute GCP audits, ensuring compliance and quality in clinical trials.
- Company: Join Veristat, a global leader in clinical development with 30 years of expertise.
- Benefits: Enjoy flexible work options, continuous training, and rewards for your achievements.
- Why this job: Be part of a dynamic team making a real impact in rare disease research.
- Qualifications: 5+ years of GCP auditing experience in FDA environments required; strong regulatory knowledge essential.
- Other info: Veristat values diversity and fosters an inclusive workplace for all employees.
The predicted salary is between 48000 - 72000 £ per year.
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The Senior GCP (Good Clinical Practices) Auditor is responsible for execution of the Audit Plan at Veristat. S/he will plan, conduct, report and follow up on all types of GCP audits, including internal audits, contracted audits and vendor audits. The Senior GCP Auditor will also provide support during sponsor audits and regulatory inspections and will support all relevant activities associated with Veristat’s Quality Management System.
What we do
For 30 years, Veristat has built a reputation as global experts in clinical development.
- 760+ Rare Disease Clinical Trials supported
- 160+ Marketing Applications supported
- In 2022 we supported 8 marketing application that received regulatory approval
- Learn more about our core values here!
What we offer
- A stimulating role in an international and dynamic work environment
- Continuous development and training opportunities
- Office or Home-Based working
- Rewards for outstanding accomplishments
What we look for
- 5+ years of relevant GCP auditing experience in a FDA Environment such as pharmaceutical, biotech or CRO company or similar environment required.
- Knowledgeable in relevant regulations and guidelines including 21CFR-Part11 and GCP.
- Fluent in Microsoft Project, Outlook, Word, Excel, and PowerPoint.
- Prior experience with electronic Quality Management Systems preferred.
Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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Sr GCP Auditor employer: TN United Kingdom
Contact Detail:
TN United Kingdom Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sr GCP Auditor
✨Tip Number 1
Make sure to familiarize yourself with the latest GCP regulations and guidelines, especially 21CFR-Part11. This knowledge will not only help you during the interview but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Highlight your experience with electronic Quality Management Systems (eQMS) during networking opportunities or interviews. If you have specific examples of how you've utilized these systems effectively, be ready to share them.
✨Tip Number 3
Connect with current or former employees of Veristat on professional networks like LinkedIn. They can provide valuable insights into the company culture and the specifics of the Senior GCP Auditor role.
✨Tip Number 4
Prepare for potential case studies or scenario-based questions that may come up during the interview. Think about past audit experiences where you had to navigate challenges and how you resolved them.
We think you need these skills to ace Sr GCP Auditor
Some tips for your application 🫡
Understand the Role: Make sure you fully understand the responsibilities of a Senior GCP Auditor at Veristat. Familiarize yourself with GCP auditing processes, relevant regulations like 21CFR-Part11, and the company's Quality Management System.
Tailor Your CV: Highlight your 5+ years of relevant GCP auditing experience in your CV. Be specific about your roles in FDA environments, and mention any experience with electronic Quality Management Systems to align with what Veristat is looking for.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your expertise in GCP auditing and your familiarity with the pharmaceutical or biotech industry. Emphasize your ability to conduct audits and support regulatory inspections.
Proofread Your Application: Before submitting, carefully proofread your application materials. Ensure there are no typos or grammatical errors, as attention to detail is crucial in auditing roles.
How to prepare for a job interview at TN United Kingdom
✨Showcase Your GCP Expertise
Make sure to highlight your 5+ years of relevant GCP auditing experience. Be prepared to discuss specific audits you've conducted and how you ensured compliance with regulations like 21CFR-Part11.
✨Familiarize Yourself with Veristat's Values
Research Veristat’s core values and be ready to explain how your personal values align with theirs. This shows that you are not only a fit for the role but also for the company culture.
✨Demonstrate Technical Proficiency
Since the role requires fluency in Microsoft Project, Outlook, Word, Excel, and PowerPoint, prepare to discuss how you've used these tools in your previous roles. Consider bringing examples of reports or presentations you've created.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions related to audit situations. Think about challenges you've faced in past audits and how you resolved them, as this will demonstrate your problem-solving skills and experience.
