A QC & Stability Chemist is required for a pharmaceutical company in Waterford. 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.
- Test and complete write up of QC raw material, packaging, finished product and stability samples in a timely & efficient manner.
- Support all other on-going laboratory functions & requirements.
- Prepare and review stability summary sheets where required.
- 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.
- 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 the documentation management system.
- Report any Deviations/Out of Specifications to Senior Chemist and complete in a timely manner.
- Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs.
- Report any defects.
- Reports directly to the QC/Stability Team Leaders.
- Qualified to a minimum of honours degree level in Analytical Chemistry, Pharmaceutical science or related discipline.
- 2 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.
- Time management.
- Strong attention to detail is critical.
- Demonstrable problem solving abilities.
- Excellent organisational skills.
- Ability to multitask & work under pressure, coping with more than one conflicting task at once.
- Excellent Communication skills, both verbal & written.
- Broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions.
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