Quality Specialist

This organisation are a globally renowned leading healthcare company, who focus upon developing revolutionary therapeutics that have a meaningful impact on patients’ health worldwide. The organisation currently employ 500 people at their biologics site in Ireland. This site is expanding rapidly due to the inception of a new project and as such they require a Quality Specialist to join their Quality team. This role is crucial to the organisation in order to strive towards their mission of positively impacting upon the progression of global medicine for future generations.

The Position:

As the Quality Specialist you will be required to provide Quality oversight, along with supporting the teams within the site with GMP activities, Operational Quality and Quality Systems. Additional responsibilities include:

  • Ensuring the continuous improvement of Quality Systems and Operational Quality.
  • Utilising expertise in Deviation/NOE/LIR coaching, GCM coaching and environmental monitoring programs.
  • Overseeing Quality Management Systems (QMSs) to ensure product quality is of the highest standard.
  • Responding proactively to the requests of customers.
  • Participating in site inspections in conjunction with regulatory bodies.

The Quality Specialist role will require 5% travel time.

The Person:

As a Quality Specialist the successful candidate will have 1 – 3 years’ experience in the Pharmaceutical or Biopharmaceutical industry sectors. This should include previous experience in a Quality role. A BSc in Science, Engineering or an equivalent discipline is required. Lean Six Sigma Yellow Belt certification and operational experience of at least 4 QMSs are required.

An in-depth knowledge of current regulatory requirements and a drive to achieve results are essential. Excellent decision-making, leadership capabilities, problem-solving skills and interpersonal skills are key criteria for the role.

This role offers an excellent remuneration package along with superb working conditions, and includes 5% travel time.

To learn more apply online or call Conor Britchfield at HRM on +353 1 6321870.

Salary: On Application Location: Cork