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 GMP Quality Specialist is responsible for assisting the Quality Assurance Team, providing administrative, technical and quality support to the business in relation to Quality Assurance related matters, ensuring regulatory compliance and to investigate quality issues.

Key Responsibilities:

  • Assist with the management and maintenance of Pharmaceutical Quality System
  • Support the development and implementation of regulatory and quality procedures
  • Communicate relevant aspects of the Quality System to employees, as necessary, in order to support product and service quality
  • Provide GxP guidance and training
  • Deal with both customers and suppliers at a technical level to investigate issues related to quality problems and customer complaints
  • Review quality documents e.g. deviations, CAPA, Change Control, Complaints, Product Quality Review, master batch records etc
  • Be involved in Client audits and Competent Authority Inspections, including arrangement, participation throughout the audit / inspection and assistance in the follow up on any findings identified from the audit / inspection

Requirements

The successful GMP Quality Specialist will have the following:

  • Hold a bachelor’s degree (or equivalent) in chemistry, Biology, Pharmacy, Pharmaceutical Chemistry or related subject
  • Experience within a Quality Assurance / Quality Control / Technical role within the pharmaceutical industry
  • Familiar with the structure of the European and UK pharmaceutical legislations, EU GMP and GDP requirements, and ICH Quality guidelines
  • Good understanding in different dosage forms
  • Knowledge on the US FDA and CFR requirements would be advantageous (but not essential)
  • Ability to communicate at all levels
  • Excellent attention to detail
  • Ability to travel is required for this role

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.