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For Companies At a Glance
- Tasks: Lead and execute GCP audits, ensuring compliance and quality in clinical practices.
- 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 impacting rare disease trials and regulatory approvals.
- Qualifications: 5+ years of GCP auditing experience in FDA environments required; strong knowledge of regulations essential.
- Other info: Veristat values diversity and fosters an inclusive workplace for all employees.
The predicted salary is between 48000 - 72000 £ per year.
time left to apply End Date: February 28, 2025 (13 days left to apply)
job requisition id R-202501519
Job Description:
Senior GCP Auditor
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 applications that received regulatory approval
- 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.
Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.
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: Veristat, Inc.
Contact Detail:
Veristat, Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sr GCP Auditor
✨Tip Number 1
Make sure to highlight your experience in GCP auditing, especially within FDA environments. Use specific examples from your past roles that demonstrate your expertise and how you've successfully conducted audits.
✨Tip Number 2
Familiarize yourself with Veristat's Quality Management System and their approach to audits. Showing that you understand their processes and values can set you apart during the interview.
✨Tip Number 3
Prepare to discuss your knowledge of relevant regulations like 21CFR-Part11 and GCP. Being able to articulate how these regulations impact auditing will demonstrate your depth of understanding.
✨Tip Number 4
Since the role involves working with various stakeholders, practice your communication skills. Be ready to explain how you would effectively collaborate with sponsors and regulatory bodies during audits.
We think you need these skills to ace Sr GCP Auditor
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior GCP Auditor position. Understand the key responsibilities and required qualifications, such as experience in GCP auditing and knowledge of relevant regulations.
Tailor Your CV: Customize your CV to highlight your 5+ years of relevant GCP auditing experience. Emphasize your familiarity with FDA environments and specific regulations like 21CFR-Part11 and GCP.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for clinical development and your expertise in GCP auditing. Mention any relevant experiences that align with Veristat's mission and values.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for any spelling or grammatical errors, and ensure that all information is accurate and well-presented.
How to prepare for a job interview at Veristat, Inc.
✨Showcase Your GCP Knowledge
Make sure to highlight your understanding of Good Clinical Practices and relevant regulations like 21CFR-Part11. Be prepared to discuss how you've applied this knowledge in previous roles.
✨Demonstrate Audit Experience
Share specific examples from your 5+ years of GCP auditing experience. Discuss the types of audits you've conducted, including internal, contracted, and vendor audits, to showcase your expertise.
✨Familiarize Yourself with Veristat
Research Veristat's history and their role in clinical development. Understanding their mission and recent achievements will help you align your answers with their values during the interview.
✨Prepare for Behavioral Questions
Expect questions that assess your problem-solving skills and ability to work in a team. Use the STAR method (Situation, Task, Action, Result) to structure your responses effectively.
