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
West Sussex is a county on the south coast of England and over many centuries the strategic location of West Sussex has played a key part in history, defence and trade. West Sussex offers a wealth of interesting places to visit from historic West Sussex towns and cities such as Chichester, Arundel and Petworth to West Sussex coastal resorts including Worthing and Bognor Regis. A substantial part of the South Downs National Park is also located in West Sussex as are many West Sussex nature reserves and areas of outstanding natural beauty. West Sussex is also a great place to live and work, with a wide range of West Sussex industries and West Sussex businesses established in towns such as Crawley, Horsham, Haywards Heath and Burgess Hill to the north of the county. Gatwick airport, one of the busiest in Europe, is a further benefit to businesses, residents and international visitors to West Sussex.
Famous people born in West Sussex: Harry Enfield, comedian and Percy Bysshe Shelley, poet, also born in West Sussex.
From world-renowned Medical and Diagnostic Technology companies, to major Pharmaceuticals and Industry Support services, West Sussex's Health and Life Sciences Cluster is booming. The country is home to over 90 diverse companies, contributing to the forefront of innovation in the Global Health and Life Sciences sector. A strong cluster has emerged in the county with collaboration between businesses, research and public health, facilitated by WSCC who is investing heavily in the growth of the sector. West Sussex provides a highly attractive offer for global and national businesses wanting to be in the forefront of innovation, in the heart of growth.
West Sussex is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in West Sussex, scientific careers in West Sussex or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities in West Sussex, give our Next Phase team a call. The West 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 West 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 West Sussex area.