Job purpose: To analyse stability products to agreed schedules and in accordance with regulatory requirements. To assist other R&D groups in the testing of In Process and Finished Product samples if required.

Reports directly to the Release and Stability Team Lead in the R&D Analytical group

Responsibilities include:

  1. To test submission stability products in a timely and efficient manner to agreed schedules and in accordance with Regulatory requirements.
  2. To assist other R&D groups in the testing of In Process and Finished Products if required.
  3. To review test methods and draft stability protocols as applicable.
  4. To prepare submission documentation in support of license applications.
  5. To take part in any laboratory investigations/troubleshooting.
  6. To trend analytical data as required.
  7. To liase directly with customers and contract laboratories and attend conference calls as required.
  8. To attend internal project review meetings as required.
  9. To assist in the preparation for customer/ regulatory inspections. 
  10. To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  11. To ensure that all work is carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  12. To complete all documentation correctly, in line with data integrity guidelines, free from errors, omissions or defects in order to achieve a high level of customer service and cGMP. To peer review documentation as required.
  13. To perform additional team tasks as agreed to support effective running of the Business.
  14. To support all other on-going laboratory functions & requirements.

Health and Safety

  1. To ensure the requirements of EirGen’s Safety Statement are implemented.
  2. To continuously promote a positive safety culture by leading by example.
  3. To implement safety requirements as per site documentation including SOP’s, Safety Statement and COP’s.
  4. To report any defects/hazards

The ideal candidate will:

  • Be qualified to a minimum of degree level in chemistry, pharmaceutical science or a related discipline.
  • Have at least two years experience working in a related technical environment.