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- Tasks: Conduct audits and ensure compliance with regulations in a dynamic pharmaceutical environment.
- Company: Join a global pharmaceutical leader dedicated to developing lifesaving medicines.
- Benefits: Enjoy hybrid working, competitive pay, 25 days holiday, and more perks.
- Why this job: Make a real impact on patient lives while growing your career in quality assurance.
- Qualifications: Ideal for those with QA experience or recent science graduates eager to learn.
- Other info: This is a temporary contract role with potential for extension.
Our global pharmaceutical client based in Moorgate, London has an exciting opportunity for an experienced QA professional to join their Global Development Quality group as a temporary contract Quality Specialist for initially 6 months, with a possible extension.
This role will expose you to the full range of investigational medicinal products in the development pipeline, from simple small molecules through to complex immunotherapy treatments, and a chance to make a real difference to patients receiving these lifesaving and life changing medicines.
As a Quality Specialist, you will be responsible for the final review of clinical batch records to ensure compliance with GMP and conformance with regulatory filings. The compilation and approval of this data pack and presentation to the QP for final release is the core function of the role, and you will work closely with global functions supporting the clinical supply chain, as well as clinical manufacturing sites internally and externally around the world to help you achieve this. Our client is therefore looking for excellent communication skills, an ability to manage issue resolution, confidence to work with minimal supervision, and a keen eye for detail. Our client offers hybrid working with 1 mandatory day in the office which may increase to 2 days a week in the future. This role pays hourly rate of £18.00 - £26 per hour, depending on experience plus 25 days holiday pro rata and other benefits.
Duties include:
- The Quality Auditor conducts routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure compliance with SOPs and GMPs and worldwide regulations.
- Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements.
- In addition, the Auditor communicates and resolves audit comments with client areas.
- Under supervision, or as part of a team, perform audits or inspections of assigned areas or systems to assess compliance with regulatory and Company standards.
- Issue reports summarizing deficiencies and work with areas to execute remedial action.
- Notify appropriate management of inspection result.
- Works with moderate work direction and is skilled and knowledgeable to the position.
Experience, Skills, Knowledge and Qualifications:
- Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations.
- Effective communications (oral/written) and interpersonal skills are necessary.
- Ideally you should have existing experience in a QA or similar role in a GMP environment, however our client would be just as interested in new science graduates (Bachelor’s degree minimum) with the right attitude and a willingness to learn.
Contact Detail:
Room At The Top Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Auditor
✨Tip Number 1
Familiarise yourself with the latest cGMP regulations and guidelines. This knowledge will not only help you in interviews but also demonstrate your commitment to quality assurance in the pharmaceutical industry.
✨Tip Number 2
Network with professionals in the QA field, especially those who work in pharmaceutical companies. Attend industry events or join relevant online forums to connect with others and gain insights into the role and company culture.
✨Tip Number 3
Prepare to discuss specific examples from your past experiences that showcase your attention to detail and problem-solving skills. Think of situations where you successfully resolved compliance issues or improved processes.
✨Tip Number 4
Research the company’s recent projects and developments in the pharmaceutical sector. Being knowledgeable about their work will allow you to ask informed questions during the interview and show your genuine interest in the position.
We think you need these skills to ace Quality Auditor
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to grasp the responsibilities and requirements of the Quality Auditor position. Highlight key skills such as communication, attention to detail, and experience in GMP compliance.
Tailor Your CV: Customise your CV to reflect relevant experience in the pharmaceutical or chemical industry. Emphasise any previous QA roles, your understanding of cGMP regulations, and any specific projects that showcase your skills.
Craft a Compelling Cover Letter: Write a cover letter that connects your background to the job. Mention your passion for quality assurance and how your skills can contribute to the company's mission of delivering lifesaving medicines.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors. Ensure that your documents are clear, concise, and free from typos, as attention to detail is crucial for this role.
How to prepare for a job interview at Room At The Top Recruitment
✨Know Your GMP Regulations
Familiarise yourself with current Good Manufacturing Practices (cGMP) regulations. Be prepared to discuss how these regulations apply to the role of a Quality Auditor and provide examples from your past experience or studies.
✨Showcase Your Communication Skills
Since effective communication is key in this role, practice articulating your thoughts clearly. Prepare to discuss how you've successfully resolved issues in previous roles, highlighting your interpersonal skills.
✨Demonstrate Attention to Detail
As a Quality Specialist, a keen eye for detail is crucial. Bring examples of how your attention to detail has positively impacted your work, especially in auditing or compliance-related tasks.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving abilities. Think of situations where you had to manage compliance issues or audit findings, and be ready to explain your approach and the outcomes.
