– Laboratory specialist responsible to conduct trace metal analysis and assay of metals by inductively coupled plasma mass spectrometry (ICP-MS) .
– Development of new methods for drug substance , intermediate and raw materials according ICHQ3D Elemental Impurities Analysis and USP General Chapters <232> and >233> . Perform quality control analysis.
– Analytical method validation protocol , execution and final report preparation.
– Writing development reports linked to the different ongoing projects, analytical tests methods and standard operation procedures (SOPs) needed to support GMP activities.
– Review of data generated by chemist
– OOS and investigation reports
– To ensure that all the work is carried out in compliance with the required standards, conforming to company, cGMP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
Candidates will need to show evidence of the following :
1. Preferably hold a degree in Chemistry
2. Very high English level is a must.
3. Must have a minimum of one year of previous experience working with ICP-MS.
4. Theoretical and practical knowledge with the implementation of ICH Q3D and USP General Chapters <232> & <233>
5. Extremely organized to deal with a variety of projects and able to priorities conflicting demands.
6. Ability to work under pressure with multiple projects to strict on-going deadlines.
7. Excellent communication skills (oral and written) and interpersonal skills.