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- Tasks: Ensure compliance with quality management systems and improve processes in a dynamic pharmaceutical environment.
- Company: Join a reputable pharmaceutical company known for its values and market leadership in quality products.
- Benefits: Enjoy a competitive salary, annual bonus, private healthcare, life assurance, and pension.
- Why this job: Make a positive impact in a growing business while promoting a strong quality culture.
- Qualifications: Degree in a scientific field or relevant experience; strong QMS knowledge is essential.
- Other info: This role offers a collaborative team environment and encourages applicants from all backgrounds.
The predicted salary is between 36000 - 60000 £ per year.
We are exclusively supporting a great Pharmaceutical business based in Hertfordshire to recruit a QMS Specialist to join them as part of continued, and very exciting growth. This is a very important hire for this business. The QMS Specialist will play a key role in supporting the wider business in ensuring that the quality management system is maintained, continuously improved and ultimately ensuring the provisions of the licenses are observed.
About the company you are joining: A very reputable and values driven Pharmaceutical business that has seen tremendous results in recent years - they really are pushing the boat in terms of establishing themselves as a market leader within their respective field, and have continued to invest heavily in growing the business, particularly within the Quality team. Our client distributes a large range of Pharmaceutical products both domestically and internationally to a diverse customer base.
About the QMS Specialist role: As QMS Specialist, you will be responsible to ensure the ongoing compliance of the company’s activities with MHRA requirements under Good Distribution Practice (GDP), Good Manufacturing Practice (GMP) guidelines and internal quality standards. You will be required to support the Head of Quality in ensuring that any decisions that impact medicinal product or MHRA regulations are communicated and agreed with the RP prior to implementation. You will also need to work closely with internal teams to continually seek to identify and implement opportunities for continuous improvement to streamline processes and reduce administrative burdens.
Some of the key responsibilities for the QMS Specialist will involve the following:
- Support the implementation, maintenance and continuous improvement of the Quality Management System (QMS) in line with GDP and GMP guidelines.
- Assist the Head of Quality in ensuring compliance with the WDA(H), MIA(IMP) and MS licence conditions.
- Consult with regulatory authorities (Home Office/MHRA) on Licence application/variation and Annual CDs returns.
- Author, review, investigate, implement and approve quality documentation, including SOPS, change controls, deviations, complaints, CAPAs and risk assessments.
- Conduct and support internal audits, self-inspections, and mock inspections, ensure timely completion of follow-up actions.
- Monitor environmental conditions for storage areas, ensuring products are maintained within labelled storage conditions.
- Liaise with customers, suppliers and third parties to ensure compliance with technical and quality agreements.
- Review and approve customers, suppliers and third-party service providers in line with GMP and GDP guidelines.
- Preparation, execution, and reporting of Regulatory inspections, Client, and Supplier audits.
The ideal candidate for the QMS Specialist will have the following background:
- Degree qualified in a Scientific or related field, or equivalent relevant industry experience.
- Proven experience in a QA role within a GMP and/or GDP compliant environment.
- Really strong Quality Management System (QMS) knowledge and experience - this is an essential part of this role.
- Strong understanding of MHRA expectations, WDA(H) licence conditions, and GDP guidelines.
- Excellent attention to detail, organisational skills, and ability to work independently.
- Competent understanding of The Human Medicines Regulations 2012.
- A really positive energy and attitude to work - thrives on working in a collaborative, team based environment.
- Has a real passion for quality and continuously promotes a strong quality culture across all aspects of their work.
What is on offer? A competitive basic salary. Annual bonus Excellent benefits package including - Private Healthcare, Life Assurance & Pension. But, most importantly, the chance for you to make a really positive mark on a great business!
Our client is an equal opportunities employer and we encourage applicants from all backgrounds. For a full job description and more detailed overview of the opportunity, please apply or reach out directly to hear more.
Contact Detail:
Radar Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QMS Specialist - Pharmaceutical
✨Tip Number 1
Familiarise yourself with the specific regulations and guidelines related to GDP and GMP. Understanding these frameworks will not only help you in interviews but also demonstrate your commitment to quality management.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who work in quality assurance roles. Engaging with them can provide insights into the company culture and expectations, which can be invaluable during your application process.
✨Tip Number 3
Prepare to discuss specific examples of how you've contributed to quality management systems in previous roles. Highlighting your hands-on experience with QMS will set you apart from other candidates.
✨Tip Number 4
Showcase your passion for quality by discussing any initiatives or improvements you've implemented in past positions. This will reflect your proactive attitude and alignment with the company's values.
We think you need these skills to ace QMS Specialist - Pharmaceutical
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Assurance, particularly within GMP and GDP compliant environments. Emphasise your knowledge of QMS and any specific achievements that demonstrate your ability to maintain and improve quality systems.
Craft a Strong Cover Letter: In your cover letter, express your passion for quality management and how it aligns with the values of the pharmaceutical business. Mention specific examples of how you've contributed to compliance and continuous improvement in previous roles.
Highlight Relevant Qualifications: Clearly state your degree qualifications and any additional certifications related to Quality Assurance or regulatory compliance. This will help demonstrate your suitability for the QMS Specialist role.
Showcase Soft Skills: Don't forget to mention your organisational skills, attention to detail, and ability to work collaboratively. These soft skills are crucial for the QMS Specialist position and can set you apart from other candidates.
How to prepare for a job interview at Radar Recruitment
✨Know Your QMS Inside Out
Make sure you have a solid understanding of Quality Management Systems, especially in relation to GMP and GDP guidelines. Be prepared to discuss specific examples from your past experience where you've successfully implemented or improved a QMS.
✨Familiarise Yourself with Regulatory Requirements
Brush up on the MHRA expectations and the relevant licensing conditions such as WDA(H) and MIA(IMP). Being able to articulate how these regulations impact the role will show your depth of knowledge and commitment to compliance.
✨Demonstrate Continuous Improvement Mindset
Think of instances where you've identified opportunities for process improvements in your previous roles. Be ready to share how you approached these situations and the positive outcomes that resulted from your initiatives.
✨Showcase Your Team Spirit
This role requires collaboration with various internal teams and external partners. Prepare to discuss how you've worked effectively in team settings, highlighting your ability to communicate and foster a strong quality culture.
