Responsible for accurate sampling of Stability product according to QC procedures and ICH guidelines.
Responsible to perform all physical and chemical checks on Stability products according to QC specifications.
Responsible to fill the required Quality Reports which contains detailed information on the performed tests and calculations according to the supplied specifications.
Responsible to apply GLP, GDP.
Responsible to exactly follow QC policies, standards, and procedures.
Responsible for create protocol, Report & COA of the stability study.
Responsible to receive and enter & withdraw stability samples & preparation.
Perform Comparative dissolution study, create Protocol & Final Report.
Respond to the EDA comments & Preparation technical File.
Participating in Method Development & Analytical method validation study. Preparation Protocol & Final report.
Follow-up development of the method of analysis of new drug molecules suitable for routine work of QC.
Development of stability-indicating assay of pharmaceutical products.
The validation of all the developed methods of analysis.
Solving any problems encountered in all the developed methods of analysis.
Documentation of MOA, Specs & work sheet.

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.css-o171kl{-webkit-text-decoration:none;text-decoration:none;color:inherit;}Stability & Methodology analyst