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 an RP
- 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
South East England
South East England is one of the nine official regions of England. It consists of Berkshire, Buckinghamshire, East Sussex, Hampshire, the Isle of Wight, Kent, Oxfordshire, Surrey and West Sussex. Greater London is usually considered as a separate region, although it too is obviously located in the South East, bordering Kent, West Sussex, Surrey and East Sussex.
Major towns and cities in the South East of the UK include Brighton and Hove, Canterbury, Chichester, Oxford, Portsmouth, Southampton, Winchester, Crawley, Reading, Milton Keynes, Horsham, Farnham and Worthing. The South East of the UK is an economic hub and is second only to London in terms of its economy thanks in part to the location of Gatwick Airport in West Sussex and numerous Channel ports on the Kent coast.
Many global companies have their UK Headquarters in the South East of the UK, including a concentration of technology companies along the “M4 corridor” and numerous technology, clinical research, pharmaceutical, biotech, life science and engineering companies are located in the various counties comprising the South East of the UK.
The 'golden triangle' is the world-leading life sciences cluster of London, Oxford, Cambridge and England's greater south east.
This region is a hotbed of innovation, home to:
Four of the world's top 10 universities
Five our of seven of the UK's academic health science centres
Leading medical research institutes including hte Wellcome Trust, the Medical Research Council, Cancer Research UK, and the national Cell Therapy Catapult, focusing on stem cell research and industrialisation.
The golden triangle is being boosted further by a wave of significant new investment, including:
The Francis Crick Institute - bringing together 1,500 scientist under one roof
Imperial West - co0locating researchers and businesses on 25 acres.
UCL East - a cross-discipline enterprise and innovation centre focused on health and biological technologies on the site of Queen Elizabeth Olympic Park.
The Institute of Cancer Research - creating the world's second largest cancer research campus in south London.
AstraZeneca's Global R&D Centre - bringing together 2,000 employees in Cambridge.
South-East England is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in the South East, scientific careers in the South East or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities inthe South East, give our Next Phase team a call. The London 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 London, 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 area.