Organisation

Clinigen Group plc is a rapidly-growing global specialty pharmaceutical and services company with a unique combination of businesses focused on delivering the right medicine to the right patient at the right time to improve the quality of people’s lives around the world. The group consists of complementary businesses that focus on key areas of global medicine supply: clinical trial, unlicensed and licensed medicines. Our businesses can operate efficiently in a complex global regulatory environment and can ensure that precious medicines are delivered securely and effectively, wherever they are needed throughout the product lifecycle.

We are currently 1200+ people, headquartered in the UK, with sites in Burton-on-Trent, Weybridge and the North East and global offices in the US, Australia, New Zealand, Japan, Hong Kong, South Africa, Singapore and Athens. Clinigen is a rapidly growing company that has a great future ahead. To sustain our growth, we’re always on the lookout for motivated, ambitious and committed individuals to join our highly successful team.

Role

The Quality Officer will monitor and assist quality assurance activities within Quantum Pharmaceutical Ltd, in order to ensure regulatory compliance with GMP and GDP as set out in the Eudralex Vol 4.

This is a 12 month maternity cover working 32.5 hours per week, Monday to Friday.

Responsibilities

  • To set up, control and maintain Pharmaceutical Quality Systems
  • Write, review and approve quality documents i.e. unplanned incidents, change requests, CAPA, procedural documents, complaints, master batch records etc.
  • Support departments with the raising and execution of quality documents i.e. unplanned incidents, change requests, CAPA, procedural documents, complaints, master batch records etc.
  • Review and approval of vendors for Quantum
  • Author, review and maintain relevant Quality Agreements
  • Lead, participate in and review all types of investigations, Root Cause Analysis and Quality Risk Management

Requirements

  • Experience of Quality Management Systems
  • Good knowledge of GxP
  • A background in the pharmaceutical industry, preferably in a quality role
  • Excellent communication skills and competence with Microsoft Word, Excel and Outlook
  • Experience of vendor approval, validation, Quality Risk Management and Root Cause Analysis would be preferable

Application

If this role is of interest to you, please email a recent copy of your CV and a covering letter to recruitment@clinigengroup.com and a member of the Talent Acquisition team will be in touch.