– 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.
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.