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
- To test submission stability products in a timely and efficient manner to agreed schedules and in accordance with Regulatory requirements.
- To assist other R&D groups in the testing of In Process and Finished Products if required.
- To review test methods and draft stability protocols as applicable.
- To prepare submission documentation in support of license applications.
- To take part in any laboratory investigations/troubleshooting.
- To trend analytical data as required.
- To liase directly with customers and contract laboratories and attend conference calls as required.
- To attend internal project review meetings as required.
- To assist in the preparation for customer/ regulatory inspections.
- To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
- 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.
- 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.
- To perform additional team tasks as agreed to support effective running of the Business.
- To support all other on-going laboratory functions & requirements.
Health and Safety
- To ensure the requirements of EirGen’s Safety Statement are implemented.
- To continuously promote a positive safety culture by leading by example.
- 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.
- Have at least two years experience working in a related technical environment.