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