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. 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
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
Approve GDP related data and documentation such as temperature mapping protocols and reports for the warehouse. to ascertain the risk to the product quality and any patient safety impact. 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
Team player, able to work with remote colleagues and diverse cultures

Be experienced in either hosting or being a key presenter with regulatory inspections
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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