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
Dundee is a coastal city on the Firth of Tay estuary in eastern Scotland. Its regenerated waterfront has 2 nautical museums: RRS Discovery, Captain Scott’s Antarctic expedition ship, and 19th-century warship, HM Frigate Unicorn. North of the water, Verdant Works is a museum celebrating the city’s jute-manufacturing heritage. The McManus: Dundee’s Art Gallery & Museum displays art and archaeological finds.
In 2014, Dundee was recognised by the United Nations as the UK's first UNESCO City of Design for its diverse contributions to fields including medical research, comics and video games.
A unique feature of Dundee is that its two professional football clubs, Dundee F.C and Dundee United F.C, have stadiums all but adjacent to each other.
Today, Dundee is promoted as "One City, Many Discoveries" in honor of Dundee's history of scientific activities and of the RRS Discovery, Robert Falcon Scott's Antarctic exploration vessel, which was built in Dundee and is now berthed at Discovery Point. Biomedical and technological industries have arrived since the 1980s, and the city now accounts for 10% of the United Kingdom's digital entertainment industry, including mobile app development and gaming.
Dundee is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in Dundee, scientific careers in Dundee or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities in Dundee, give our Next Phase team a call. The Scottish 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 Scotland, 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 Scottish area.