At a Glance
- Tasks: Conduct audits of suppliers and ensure compliance with pharmaceutical standards.
- Company: Join Diomed's Quality Assurance team in a dynamic environment.
- Benefits: Competitive salary, professional development, and opportunities for growth.
- Other info: Collaborate with diverse teams and stay updated on industry best practices.
- Why this job: Make a real impact on quality assurance in the pharmaceutical industry.
- Qualifications: Strong communication skills and knowledge of GMP regulations required.
The predicted salary is between 40000 - 50000 £ per year.
An opportunity has arisen to join the Diomed Quality Assurance team as an External Auditor. The auditor role will involve planning, conducting, documenting and concluding audits of Contract organisations and suppliers to Diomed. The role requires the successful applicant to consult with key stakeholders in Diomed to meticulously plan and carry out supplier audits across UK and overseas supplier sites before summarising, reporting and closing out of the audit. An excellent knowledge of regulatory requirements relating to GxP is required.
Your key responsibilities will be to:
- Conduct supplier audits of manufacturing facilities, laboratories, and quality systems to assess quality systems and ensure compliance with pharmaceutical standards including GMP (Good Manufacturing Practice), EMA, and other relevant regulatory requirements.
- Review and evaluate Standard Operating Procedures (SOPs), batch records, validation protocols, and quality documentation.
- Identify non-conformances, deviations, and areas for improvement; provide actionable recommendations.
- Prepare detailed audit reports with findings, observations, and corrective action plans.
- Track and verify implementation of Corrective and Preventive Actions (CAPA).
- Support regulatory inspections and external audits.
- Stay current with evolving pharmaceutical regulations and industry best practices.
- Collaborate with cross-functional teams including Production, Manufacturing, Engineering, Purchasing and Supply, and Regulatory Affairs.
- Conduct risk assessments and participate in quality improvement initiatives.
- Perform other routine tasks, as required.
What you’ll need to succeed:
- Exceptional written and verbal communication skills.
- Strong attention to detail and ability to identify compliance gaps.
- Excellent analytical and problem-solving skills.
- Well organised and motivated individual.
- Ability to plan and work well on own initiative.
- Computer literate: able to use Microsoft Office, standard databases, and Quality Management Systems.
- Certified Auditor.
- Strong knowledge of GMP, FDA 21 CFR Parts 210/211, ICH guidelines, and other pharmaceutical regulations.
- Previous experience in a similar role is essential.
Quality Assurance Auditor employer: Diomed Developments Ltd.
At Diomed, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. As a Quality Assurance Auditor, you will benefit from comprehensive training and development opportunities, ensuring your professional growth while working alongside industry experts. Our commitment to employee well-being is reflected in our supportive environment, competitive benefits, and the chance to make a meaningful impact in the pharmaceutical sector, both in the UK and internationally.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance Auditor
✨Tip Number 1
Network like a pro! Reach out to professionals in the Quality Assurance field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be when it comes to landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP and regulatory requirements. We recommend creating a cheat sheet of key points to discuss, so you can impress your interviewers with your expertise.
✨Tip Number 3
Showcase your skills through practical examples. When discussing your experience, we suggest using the STAR method (Situation, Task, Action, Result) to clearly demonstrate how you've tackled challenges in previous roles.
✨Tip Number 4
Don’t forget to apply directly through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows your enthusiasm for joining the Diomed team!
We think you need these skills to ace Quality Assurance Auditor
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Assurance Auditor role. Highlight your experience with GxP regulations and any relevant auditing experience. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and how your background makes you a perfect fit for our team. Don’t forget to mention your knowledge of GMP and regulatory requirements.
Showcase Your Attention to Detail:As an auditor, attention to detail is key. In your application, provide examples of how you've identified compliance gaps or improved processes in previous roles. We love seeing candidates who can spot the finer points!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Diomed Developments Ltd.
✨Know Your Regulations
Make sure you brush up on your knowledge of GMP, FDA 21 CFR Parts 210/211, and ICH guidelines. Being able to discuss these regulations confidently will show that you're not just familiar with them, but that you understand their importance in the auditing process.
✨Prepare for Scenario Questions
Expect to be asked about specific situations you've encountered in previous roles. Think of examples where you've identified non-conformances or implemented corrective actions. This will demonstrate your analytical skills and problem-solving abilities.
✨Showcase Your Communication Skills
As an auditor, you'll need to communicate findings clearly. Practice articulating your thoughts on audit reports and recommendations. You might even want to prepare a mock report to discuss during the interview to highlight your written communication skills.
✨Demonstrate Organisational Skills
Being well-organised is crucial for this role. Bring along a planner or digital tool that showcases how you manage your time and tasks. Discuss how you prioritise audits and track CAPA implementation to illustrate your proactive approach.
