Responsabilities:
– Conduct stability studies of intermediates and active substances as per predefined protocol , data compilation and evaluation as per ICH guidelines.
– Analysis of finished products as per the specifications, MoA and data compilation.
– Analytical method validation protocol , execution and final report preparation.
– Analytical method transfer.
– Write standard operation procedures, analytical tests methods, protocols/reports for various analytical projects , or stability reports, when required.
– 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 three years of previous experience of working within a QC Lab , but experience in analytical development will be also valuable.
4. Theoretical and practical knowledge of various analytical techniques such as HPLC, GC, GC-HS, IC, FT-IR, PSD, KF titration.
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 (oral and written) and interpersonal skills.
