The successful candidate will support QC and Stability by ensuring all raw materials, packaging, finished products and Stability samples are analysed in accordance with cGxP.
- To test and complete write up of QC raw material, packaging, finished product and stability samples in a timely & efficient manner.
- To support all other on-going laboratory functions & requirements.
- To prepare and review stability summary sheets where required.
- 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.
- Check own work and that of others for accuracy.
- To assist in the preparation for internal / customer/ regulatory inspections.
- Involved in internal investigations e.g. Out of Specifications, Incidents & Deviation investigations etc
- Draft, review or revise documentation within EirGen documentation management system
- Report any Deviations/Out of Specifications to Senior Chemist and complete in a timely manner
- Health & Safety
- Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
- Qualified to a minimum of honours degree level in Analytical Chemistry, Pharmaceutical science or related discipline.
- At least two years experience working in a related technical environment is preferable but not essential.
- Proficient in the use of HPLC & associated problem solving
- Proficient with Dissolution testing
- Strong analytical ability
- Quality Orientation
- Knowledge & proficiency of Microsoft products including, Excel, Word & Powerpoint.
- Adaptability - maintain effectiveness in varying environments and with different tasks, responsibilities and people
- Broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.