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 800+ people, headquartered in the UK with sites and subsidiaries in Burton-on-Trent, Weybridge, 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

We currently have two Quality Control Officer opportunities available to work in our Byfleet office.

Reporting to the Quality Manager, the Quality Control Officer will be responsible for assisting the Quality and Warehouse teams, providing administrative, technical and quality support to the business in relation to all Quality matters.

Responsibilities

  • Perform batch release activities on finished medicinal products.
  • Review and approve artwork proofs and artwork components.
  • Perform quarantine release on finished medicinal products.
  • Handle all discrepancies, non-conformances and damages on finished medicinal products.
  • Create, review and approve warehouse stock movements.
  • Upload of certificate of analysis / certificate of conformance to Clinigen electronic system.
  • Create, review and approve change controls, deviations and CAPAs.
  • Create, review and approve relevant standard operating procedures, work instructions and forms.
  • Deal and manage temperature excursions (inbound/outbound/on-site excursions).

The list of duties is not intended to be exhaustive, but gives a general indication of the tasks involved. It is the nature of the company that tasks and responsibilities are, in many circumstances, unpredictable and varied.

Requirements

  • Life Sciences Graduate, Pharmacist or Chemist (or equivalent)
  • 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.
  • Ability to self-motivate and self-disciplined.
  • Excellent IT, planning, administrative and organisational skills.
  • 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.