Purpose: To support the laboratory in the day to day functions as required in accordance with all cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines. To maintain laboratory equipment and to perform calibrations as per schedules.
- To maintain all associated documentation for equipment in the laboratory.
- To assist the instrumentation engineer as required.
- To carry out water testing and environmental monitoring as required in accordance with current company SOP’s.
- To log samples into the laboratory and complete associated documentation.
- To remove all laboratory waste in a safe manner and as per current company SOP’s.
- To clean glassware within the laboratory and to clean all lab areas periodically i.e. bench tops , shelves.
- To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
- To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
- To assist in the preparation for internal / customer/ regulatory inspections.
- To be involved in internal investigations e.g. Out of Specifications, Incidents & Deviation investigations etc. as required.
- To draft, review or revise documentation within EirGen documentation management system.
- To report any Deviations/Out of Specifications to Team Leads and assist in the completion of such in a timely manner.
- Health & Safety
- To implement safety requirements as per site documentation including SOPs, Safety Statement and COPs.
- To report any defects.
- To test the Safety Shower on a weekly basis. Maintain stocks of Diphoterine within the lab and replace expired Diphoterine units.
The ideal candidate will:
- Hold a qualification in Analytical Chemistry, Pharmaceutical science or related discipline.
- Experience in a GMP regulated environment would be desirable but not essential.