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 Release Specialist is responsible for assisting the Quality and Warehouse teams, providing administrative, technical and quality support to the business in relation to all Quality matters.

Key Responsibilities:

  • Effectively manage the operational tasks within the Quality Management System (QMS) including but not limited to:
    • change controls
    • non-conformances
    • CAPAs
    • risk management
  • Create, review and approve relevant standard operating procedures, work instructions and forms
  • Maintain Clinigen paper and electronic records for quality documentation
  • Deal with both internal/external customers and suppliers at a technical level to investigate issues related to quality problems and customer complaints
  • Participate and support in internal, external and Regulatory audit programs. This includes report writing and managing of audit observations/responses
  • Act as a key Quality stakeholder on relevant Business projects

Requirements

The successful Quality Release Specialist will have the following:

  • Life Sciences Graduate, Pharmacist or Chemist.
  • Experience within a quality assurance role, or related.
  • Knowledge of Guidelines on GMP and GDP of medicinal products for human use.
  • Understanding on the conditions of the WDA(H), MS, MIA(IMP) licences.
  • Ability to communicate at all levels.
  • Excellent IT, planning, administrative and organisational skills.
  • Solutions orientated.
  • Ability to change priorities and act urgently as and when required.
  • Excellent attention to detail.

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.