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- Tasks: Ensure compliance with quality management systems and improve processes in a pharmaceutical setting.
- Company: Join a reputable pharmaceutical company leading the market with innovative growth and strong values.
- Benefits: Enjoy a competitive salary, annual bonus, private healthcare, life assurance, and pension.
- Why this job: Make a positive impact in a collaborative environment while promoting a strong quality culture.
- Qualifications: Degree in a scientific field or relevant experience; strong QMS knowledge and attention to detail required.
- Other info: This role offers a chance to grow within a dynamic team and contribute to exciting projects.
The predicted salary is between 36000 - 60000 £ per year.
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Direct message the job poster from Radar Recruitment
Director at Radar Recruitment | Scientific Disciplines | Search & Selection – Mid to Exec Level Appointments | Driving performance through people
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. This is an exclusively managed recruiting process by Radar Recruitment. All applicants (including third party/unsolicited approaches) will be managed by Radar Recruitment.
Keywords: QMS Specialist, Quality Management System Specialist, Quality Specialist, QA Specialist, Quality Assurance Specialist
Seniority level
-
Seniority level
Mid-Senior level
Employment type
-
Employment type
Full-time
Job function
-
Job function
Quality Assurance
-
Industries
Pharmaceutical Manufacturing
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QMS Specialist - Pharmaceutical employer: Radar Recruitment
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 Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP). Understanding these 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 your experience with Quality Management Systems (QMS) in detail. Be ready to share specific examples of how you've contributed to compliance and continuous improvement in previous roles, as this will highlight your suitability for the position.
✨Tip Number 4
Showcase your passion for quality and teamwork during any interactions with the hiring team. Companies like ours value candidates who not only have the right skills but also a positive attitude and a collaborative spirit.
We think you need these skills to ace QMS Specialist - Pharmaceutical
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a QMS Specialist. Familiarise yourself with terms like Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) to demonstrate your knowledge in your application.
Tailor Your CV: Highlight your relevant experience in Quality Assurance roles, especially within GMP and GDP compliant environments. Use specific examples that showcase your understanding of quality management systems and regulatory compliance.
Craft a Strong Cover Letter: In your cover letter, express your passion for quality and continuous improvement. Mention how your background aligns with the company's values and how you can contribute to their growth as a market leader in the pharmaceutical industry.
Proofread Your Application: Ensure your application is free from spelling and grammatical errors. A polished application reflects your attention to detail, which is crucial for a role focused on quality management.
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 requirements and other relevant regulations. Being able to articulate how these regulations impact the role will show that you're not just knowledgeable but also proactive about compliance.
✨Demonstrate Continuous Improvement Mindset
Think of instances where you've identified opportunities for process improvements in previous roles. Be ready to share these examples and explain how they benefited the organisation, as this aligns with the company's focus on continuous improvement.
✨Show Your Collaborative Spirit
This role requires working closely with various teams. Prepare to discuss how you've successfully collaborated with others in the past, highlighting your ability to communicate effectively and foster a positive team environment.
