Jitendra Patel
Sr analytical chemist
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About
▪ Perform analytical test according to the in-house methods, Method validation protocols, Method transfer protocols, USP monograph and SOP in compliance with cGMP, cGLP.
▪ Perform analytical testing in support of Finished-products, intermediates, Method validation samples, Method transfer samples, cleaning verification samples based on requirement and Stability studies.
▪ Expertise with HPLC and UPLC analytical techniques for Related Compounds (impurities), Assay, content uniformity and dissolution test.
▪ Experience with GC analytical technique for Assay and Residual Solvent in API and finished products.
▪ Review and approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards as required.
▪ Serve as data reviewer of SOPs, work instructions, forms and internal or external analyses.
▪ Experience with additional analytical techniques TOC, UV-Visible and Conductivity.
▪ Notify management of unexpected results, procedural deviation and equipment problems.
▪ Investigation for critical deviation and OOS and OOT results.
▪ Experienced in Empower data stations.
▪ Performed standard quality control analytical assays for the testing of in-process and final products for release and stability purposes.
▪ Developing new analytical methods, designing and performing method validations, writing of method validation protocols and reports.
▪ Preparing protocols and reports for cleaning validations and performing cleaning validations.
▪ Performing supervision of the daily laboratory activities and performing analysis on the bench.
▪ Troubleshooting problems and leading laboratory investigations of out-of-specification (OOS) results using Track Wise Quality Management Software and communicate for guidance and follow-up.
Experience
▪ Perform analytical test according to the in-house methods, Method validation protocols, Method transfer protocols, USP monograph and SOP in compliance with cGMP, cGLP.
▪ Perform analytical testing in support of Finished-products, intermediates, Method validation samples, Method transfer samples, cleaning verification samples based on requirement and Stability studies.
▪ Expertise with HPLC and UPLC analytical techniques for Related Compounds (impurities), Assay, content uniformity and dissolution test.
▪ Experience with GC analytical technique for Assay and Residual Solvent in API and finished products.
▪ Review and approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards as required.
▪ Serve as data reviewer of SOPs, work instructions, forms and internal or external analyses.
▪ Experience with additional analytical techniques TOC, UV-Visible and Conductivity.
▪ Notify management of unexpected results, procedural deviation and equipment problems.
▪ Investigation for critical deviation and OOS and OOT results.
▪ Experienced in Empower data stations.
▪ Performed standard quality control analytical assays for the testing of in-process and final products for release and stability purposes.
▪ Developing new analytical methods, designing and performing method validations, writing of method validation protocols and reports.
▪ Preparing protocols and reports for cleaning validations and performing cleaning validations.
▪ Performing supervision of the daily laboratory activities and performing analysis on the bench.
▪ Troubleshooting problems and leading laboratory investigations of out-of-specification (OOS) results using Track Wise Quality Management Software and communicate for guidance and follow-up.
Education
Master of sciences in chemistry
