Responsibilities:

–  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.

Experience:

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.