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
Ireland's Life Sciences sector has grown rapidly from modest beginnings in the 1960s to reach global significance. Collaborative clusters in Pharmaceutical, Biotechnology, Medical Devices and Diagnostics have been a key element behind this remarkable growth in a sector that accounts for 32% of GDP.
The sector continues to develop and evolve, more recently Ireland has expanded its global hub beyond commercialisation to include innovation, digitalisation and next generation technologies.
Ireland is the 3rd largest exporter of pharmaceuticals globally.
85+ Pharmaceutical companies operate in Ireland - and it has 9 of the world's top pharmaceutical companies.
50 FDA approved pharma and biopharma plants.
Dublin is the capital and largest city of Ireland. Situated on a bay on the East Coast, at the mouth of the River Liffey, it lies within the province of Leinster. It is bordered on the south by the Dublin Mountains, a part of the Wicklow Mountains range.
Dublin is the largest centre of education in Ireland, and is home to four universities and a number of other higher education institutions. It was the European Capital of Science in 2012.
The University of Dublin is the oldest University in Ireland, dating from the 16th century, and is located in the city centre. Its sole constituent college, Trinity College (TCD), was established by Royal Charter in 1592 under Elizabeth I. It was closed to Roman Catholics until 1793, and the Catholic hierarchy then banned Roman Catholics from attending until 1970. It is situated in the city centre, on College Green, and has over 18,000 students.
The National University of Ireland (NUI) has its seat in Dublin, which is also the location of the associated constituent university of University College Dublin (UCD), which has over 30,000 students. Founded in 1854, it is now the largest university in Ireland.
As of 2019, Dublin's principal, and Ireland's largest, institution for technological education and research, Dublin Institute of Technology (DIT), with origins in 1887, has merged with two majour suburban third level institutions, Institute of Technology, Tallaght and Institute of Technology, Blanchardstown, to form Technological University Dublin, Ireland's second largest university by student population. The new university offers a wide range of courses in areas including engineering, architecture, scieces, health, journalism, digital media, hospitality, business, art and design, music and the humanities programmes, and has three long-term campuses, at Grangegorman, Tallaght and Blanchardstown.
Dublin City University (DCU), formerly the National Institute for Higher Education (NIHE) Dublin, offers courses in business, engineering, science, communication courses, languages and primary education. It has around 16,000 students.
The Royal College of Surgeons in Ireland (RCSI) conducts a medical school which is both a university and a recognised college, there are also large medical schools within UCD and Trinity College. The National College of Ireland is also based in Dublin, as well as the Economic and Social Research Institute, a social science research institute.
Ireland is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in Dublin, scientific careers in Dublin or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities in Dublin, give our Next Phase team a call. The Irish 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 Dublin, 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 Dublin area.