Responsible Person (RP)
The MHRA and the European GDP Guideline of 5 November 2013 require that, in order to gain and retain a Wholesale Dealer’s Licence (WDA) licence, wholesale pharmaceutical distributors must designate a Responsible Person (RP) for Good Distribution of Medicinal (GDP) who must be named on the licence. The responsibilities and liabilities of the RP remain the same whether the Responsible person is employed directly by the licence holder or is an independent contractor.
According to the MHRA, the RP is responsible for “safeguarding product users against potential hazards arising from poor distribution practices”. The duties and responsibilities of a RP includeensuring that the provisions of the licence are fulfilled by means of GDP and GMP compliance and best practice within all regulated activities, a compliant quality system is established and maintained and a suitable document control system is in place to ensure that adequate records are maintained. In addition, the RP will need to oversee the audit of the quality system, carry out independent audits and cooperate with the product licence holder and regulatory authorities with regard to drug returns and product recalls.
In order to carry out his/her duties, the RP should have knowledge of the products being traded under the licence and the conditions necessary for their safe storage and distribution. The RP should have access to all areas and records which relate to the licensable activities and regularly review and monitor all such areas.
Skills and Experience required to become a Responsible Person
- Degree in pharmacy (preferable) or Qualified Person status
- Practical experience in Supply Chain, Production and Quality Assurance relating to the distribution of medicinal products
- Extensive knowledge of GDP and GMP
- Experience of hosting MHRA inspections, client audits and self-inspections
- High level of accuracy
East Sussex is a county in south East England to the south of London and bordered by the English Channel to the south. Major towns in East Sussex include Brighton and Hove, Lewes, Eastbourne, Rye and Hastings. Transport links in East Sussex are not particularly good as there are no motorways, but this doesn’t stop thousands of people visiting the beautiful coastline, rolling countryside and cosmopolitan Brighton, which means that the tourism industry is a major employer in this area. Other industries that are prominent in East Sussex include Pharmaceuticals, low carbon technologies, publishing, web & app design and Medical Communications. The otherwise quiet town of Lewes hosts the largest bonfire Night celebrations in the UK during which burning crosses and effigies are paraded through the town by 7 separate bonfire societies, watched by crowds of up to 80,000.
East Sussex has a School of Life Science which is a diverse, collaborative community with expertise in areas as varied as cancer biology, drug discovery, neurosciene and biodiversity. The University of Sussex is a leading research-intensive university near Brighton. We have both an international and local outlook, with staff and students from more than 100 countries and frequent engagement in community activities and services.
East Sussex has a small but growing life sciences and healthcare cluster of companies specialising in the research, development and manufacture of medical devices, biotechnology, poharmaceutical products and preparations and natural science and engineering research.
Daval International Ltd in Eastbourne focuses on the development and delivery of new treatments for neuro-degenerative, inflammatory and autoimmune diseases.
Companies also supply specialist services and instruments for life science labs and biotechnology industries. These include temperature monitoring systems (QCBug) and bespoke software solutions (Biomedical Computing Ltd).
Famous people born in East Sussex: Jo Brand, comedienne and Katie Price, “celebrity”
East Sussex is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in East Sussex, scientific careers in East Sussex or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities in East Sussex, give our Next Phase team a call. The East Sussex area is continuing to expand as a centre for jobs in science, process development, technology, software development, project management, informatics, quality, reg affairs and supply chain.
At Next Phase we help people find new jobs in life sciences across the UK, Europe and USA. This page lists some of the job opportunities in East Sussex, and if you give us a call we can also talk to you about other scientific jobs, pharmaceutical career opportunities and the latest updates in cell and gene therapy and ATMP development in the East Sussex area.