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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
Wrexham is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in Wales, scientific careers in Wales or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities inWales, give our Next Phase team a call. The Welsh 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.
Wrexham is a large market town and the administrative centre of Wrexham County Borough in Wales. It is located between the Welsh mountains and the lower Dee Valley neighboring the English county of Cheshire.
Named after the 14th century scholar and last Welsh Prince of Wales, Owain Glyndŵr, Wrexham Glyndŵr University was formed when the North East Wales Institute (NEWI) was granted full university status in 2008. It consists of Plas Coch campus in the western part of the town and the North Wales School of Art and Design located on Regent Street. The institution was founded in 1887 as the Wrexham School of Science and Art.
Glyndŵr remains an accredited institution of the University of Wales and offers both undergraduate and postgraduate degrees. Glyndŵr has approximately 8,000 full-time students and over 350 from outside the UK, although not all on the Wrexham campus.
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 Wales, 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 UK area.