QC CHEMIST – FILL FINISH

The purpose of this job is to support product development, clinical supply and launch of parenteral products, and to Support Fill Finish quality related tasks.

Responsibilities of this role include: 

  1. To draft/ review test methods.
  2. To take part in laboratory and operation investigations as required.
  3. To liase directly with customers and contract laboratories and attend conference calls as required.
  4. To attend internal project review meetings as required.
  5. To assist in the preparation for customer/ regulatory inspections. 
  6. To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  7. 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.
  8. 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.
  9. To perform additional team tasks as agreed to support effective running of the Business.
  10. To support all other on-going laboratory functions & requirements.
  11. To perform AQLs as required on Raw Material and Finished Products.
  12. To perform inspection of Stability and Retention samples as required.
  13. To support Fill Finish with Foreign matter investigations. (Identity, trending and Investigations)

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.

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. .