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
Yorkshire, formally known as the County of York, is a historic county of Northern England and the largest in the United Kingdom. Because of its great size in comparison with other English counties, functions have been undertaken over time by its subdivisions which have also been subject to periodic reform. Throughout these changes, Yorkshire has continued to be recognised as a geographic territory and cultural region. The name is familiar and well understood across the United Kingdom and is in common use in the media and the military, and also features in the titles of current areas of civil administration such as North Yorkshire, South Yorkshire, West Yorkshire and the East Riding of Yorkshire.
Within the borders of the historic county of Yorkshire are large stretches of unspoiled countryside, particularly within the Yorkshire Dales, North York Moors and Peak District National parks. Yorkshire has been nicknamed "God's Own Country".
The emblem of Yorkshire is the White Rose of the English royal House of York.
There is an excellence in Yorkshire when it comes to life science, Leeds are leading the way in medical technology in diagnostics and imagine, and York for health economics.
Yorkshire is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in Yorkshire, scientific careers in Yorkshire or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities inYorkshire, give our Next Phase team a call. The Northern 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 Yorkshire, 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 Northern England area.