At a Glance
- Tasks: Conduct audits to ensure compliance and improve quality in clinical research.
- Company: Join Celerion, a leader in clinical research with a mission to save lives.
- Benefits: Enjoy a hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Dynamic team environment with a focus on innovation and collaboration.
- Why this job: Be part of groundbreaking research that brings life-saving treatments to market faster.
- Qualifications: Bachelor's degree and 2-5 years of quality assurance experience required.
The predicted salary is between 30000 - 40000 £ per year.
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion offers one of the most experienced clinical pharmacology research networks in the industry.
The successful candidate will have Quality Assurance expertise within a GCP environment. This role will be located at our Belfast, Northern Ireland facility.
Role:The role of the Quality Assurance Auditor is to assess and assure study, project and process compliance with protocols, Controlled documents, and applicable regulations and guidelines through audits.
Responsibilities:- Carry out auditing of study, project, and process reports, records and data; report audit findings to operations via QA audit reports; and determine acceptability of the responses and verify the corrections (includes but not limited to Clinical Study Report audits, Protocol audits and Electronic Database Capture (EDC) audits).
- Interact with internal and external clients to discuss QA observations and study-related issues; and maintain effective and professional working relationships within and across departments in relation to study projects.
- Participate and lead in the improvement initiatives intended to improve quality, compliance of study, project data and reports; effectiveness and efficiency of the processes.
- Detect quality issues and the need for CAPAs and evaluate deviations.
- Assist with the preparation for and hosting of client audits and/or regulatory inspections.
- Participate in the preparation, conduct and follow-up for System Audits and Vendor Audits.
- Bachelors degree in science, IT, business, or similar.
- 2-5 years of quality/laboratory/clinical experience.
- Excellent oral and written communication skills.
- Ability to organize and manage multiple priorities.
- Excellent time management skills.
- Attention to detail, tactful, and diplomatic.
- Proficiency in using electronic data and computerized systems.
- Ability to travel, as needed.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Quality Assurance Auditor in Lisburn employer: Celerion
Celerion is an exceptional employer that fosters a collaborative and innovative work culture, where employees are empowered to contribute to life-saving treatments. Located in Belfast, Northern Ireland, our hybrid work model offers flexibility while providing ample opportunities for professional growth and development within the rapidly expanding field of clinical research. Join us to be part of a dedicated team that values quality, compliance, and continuous improvement in the pursuit of excellence.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance Auditor in Lisburn
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Celerion. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Celerion.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Celerion. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Celerion is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Quality Assurance Auditor in Lisburn
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Celerion!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Celerion that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Celerion!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Celerion, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Celerion
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Celerion that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Celerion’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
