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:
- To draft/ review test methods.
- To take part in laboratory and operation investigations 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.
- To perform AQLs as required on Raw Material and Finished Products.
- To perform inspection of Stability and Retention samples as required.
- To support Fill Finish with Foreign matter investigations. (Identity, trending and Investigations)
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. .