Deputy Manager ( Quality Control)
CurrentPresent job profile:( Quality control Department).Routine Shift handling for analysis in Quality control department. Data review and online monitoring of analysis planned in Shift i.e Assay, Dissolution and related substance test.Taking QMS in analytical test if any odd results observed and hypotheses planned to rule out root cause.Multimedia dissolution profiles report preparation in comparison with innovator sample for CRL queries. Past job profile (Analytical Development Laboratories )Daily allocation of routine analysis to the subordinates.Execution to the down line for analytical method development of generic products such as tablets, capsules, ophthalmic etc.Handling technical problems related to analytical method development for test such as assay, related substance and dissolution.Indent requires materials such as impurities, column, reagents etc.Review of Analytical Data, Calibration data, SOP etc.Review of analytical method validation protocol and its reports.Preparation of analytical method validation protocol and its reports. Validation of analytical method for assay, dissolution, related substances.Monthly/Quarterly calibration of HPLC systems, Dissolution apparatus etc.Technology transfer of analytical methods from ADL to manufacturing site.Ensuring online documentation with adequately maintaining their records. Analysis of Pharmaceuticals finished products Such as Tablets, capsule, Syrup Ointment, Cream etc.SkillsDevelopment | Equipment Qualification | Gas Chromatography | Research and Development (R&D) | Analytical R&D | Global Drug Development | Troubleshooting | Problem-Solving | Product Testing | Manufacturing | Analytical Method Validation| Quality Control (QC) | | Analytical Skills | Analytical Chemistry | Standard Operating Procedure (SOP) | Data Reviewing & Data Integrity | Good Laboratory Practice (cGLP) | Troubleshooting | Chromatography
