Responsible Person UK

1 month ago

Wooburn Green Buckinghamshire, United Kingdom Ethypharm Full time

Ethypharm is a European pharmaceutical laboratory whose mission is to improve patients’ lives by providing essential drugs focusing on hospital care, central nervous system (severe pain, addiction) and internal medicine.

The role of the Responsible Person is based out of our commercial sites in High Wycombe and/or Brentwood, reporting to our QMS Manager UK.

In this role you will be responsible for the management and monitoring the compliance of our UK distribution activities in line with GDP guidelines and within the framework of the Group Quality Policy. You will also have oversight of the QMS in relation to our Brentwood warehouse operations. In addition, you will provide direction, guidance and support to staff in terms of GDP compliance.

Main responsibilities:

  • Be named as a Responsible Person in the WDA and be a point of contact for the MHRA, working together with other RP / RPi on the license.
  • Ensure relevant GDP and warehouse activities are adequately controlled within procedures.
  • Conduct internal audits of GDP activities, bonefide checks, warehouse pest control, temperature monitoring etc. Drive continuous improvement in areas such as data logger usage, isothermic packaging, labelling
  • Participate in external audits of pre-wholesaler and logistics providers
  • Ensure technical agreements or service level agreements are in place with logistics providers
  • Manage change controls and follow the implementation of action plans in collaboration with the services concerned
  • Monitor the advancement of CAPAs and ensure compliance with required timelines
  • Contribute to the Quality Review Group for the warehouse and GDP. Trend the Key Performance Indicators for Quality Activities associated to the warehouse and GDP
  • Create an annual report on distribution routes within the UK and international routes to identify any significant issues and work with the team to root cause and agree improvements
  • Approve GDP related data and documentation such as temperature mapping protocols and reports for the warehouse. Oversight of any validation activities within the area
  • Coordinate investigations following deviations (unexpected events, out of specifications etc.) to ascertain the risk to the product quality and any patient safety impact. Make decisions following identification of the issues and determine the corrective actions to be implemented with the relevant business partners
  • Recommend usage decision for product returns in line with company policy. Work closely with the Qualified Persons certifying product to ensure an informed usage decision is made where product has been exposed to temperature excursions

About you

  • Excellent time management, communications, decision-making, and organisation skills
  • Positive mindset, ethical yet pragmatic
  • Team player, able to work with remote colleagues and diverse cultures

Skills/Education

  • You should be educated to degree level preferably in a relevant science discipline
  • Have 2 years’ experience of working in a distribution and GDP environment
  • Be experienced in either hosting or being a key presenter with regulatory inspections
  • Must be knowledgeable and have experience in UK and EU distribution requirements
  • Have some experience of working as a Responsible Person

At Ethypharm we recognise the value of diversity in the workplace and provide equal opportunities for all. We are always open to discussing flexible working arrangements where this meets with the needs of our business. Visit our website at to learn more about Ethypharm.

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