Assisting analytical method development, validation, and technology transfer for complex non-oral formulations forms like lyophilized Injections, parental, oncology products, lipid-based injections, NCE projects, and ophthalmic solution.Executing 360-degree review including document review (Development and validation protocol and reports, STPs, specifications, COAs,).Directing delivery of Physico-chemical characterizations and analytical methods, timely data & process knowledge needed to meet project milestones and associated regulatory requirements.Developing & implementing quality standards and specifications for drug substance & drug products and ensuring the delivery of high-quality sections; addressing quality-related inquiries from regulatory.Maintaining quality management systems through SOP management, deviation management, investigation of deviations to root cause & conclude, knowledge of corrective & preventive actions (CAPA), change control management.The operation, calibration, and troubleshooting of Analytical techniques like All makes HPLC and UPLC with UV-Vis, PDA, CAD, RI, an ELSD detector, Particle size determination (Malvern master size 2000 & 3000, particle size analyzer and Malvern zeta sizer Nano ZS), Ion Chromatography (Make: DIONEX ICX 5000).Operation of optima XPN 100K ultracentrifuge, Fourier transform infrared (FT-IR) (Make: Perkin Elmer), Solid-phase extraction, Karl Fischer titrator and KF coulometer for Water Content Determination, dissolution test apparatus USP I and USP II (Make: Electrolab, Lab India, Vankel), USP-IV (Make: Sotex), and Franz Diffusion Cell (Make: Henson Research), Spectro-photometer: Shimadzu phara Spec. UV-1700.Supervising cGMP/GDP and safety compliance with timely implementation of SOP. Building & maintaining a QMS to adequately control risks, ensuring harmonization between Chemical & Formulations processes.Managing method development for reverse engineering to quantify of Excipients in the RLD formulation.

Performing method development, method validation, and technology transfer of analytical methods for non-oral and oral formulations forms like lyophilized Injections, small and large volume parental, oncology products, hormonal products, and ophthalmic solution.The operation, calibration, and troubleshooting of HPLC/UPLC/IC, dissolution apparatus, GC, FTIR, and Mass spectrophotometer.Follow analytical test methods, compendia method experimental procedure, and SOPs.Document test results in a laboratory notebook, in real-time, and communicate the status of results to the supervisor. Maintain control of all projects related method development and method validation reports.Manage responsibilities and work in an efficient manner to assure and timely data reports. Consult and work closely with supervisor regarding any issues with sample preparation, instrument performance, data acquisition, and analysis as to applies to data integrity and accuracy.Train on all the SOPs and company procedures on regular basis and remain up to date with the training curriculum.

Performing method development, method validation, and technology transfer of analytical methods for solid oral formulations forms like, oncology products and tablets and capsules.Maintain accurate records regarding the maintenance and calibration activities. Performing method development, method validation, and technology transfer of analytical methods for solid oral formulations forms like, oncology products and tablets and capsules.The operation, calibration, and troubleshoot of HPLC/UPLC/IC, dissolution apparatus, GC, FTIR, and Karl Fischer Titrator, and KF Coulometer for Water Content Determination.Follow analytical test methods, compendia method experimental procedure, and SOPs.Develop analytical methods that are accurate, precise, and specific for use in both the Quality Control department and the Process Development department. Document the development of the method in the appropriate notebooks for future reference.Prepare reports for test methods and supporting documentation for use in the laboratory.Assesses all data elements required for assay validation as per the current USP and other regulatory requirements. Perform protocols as written and documents the results in the form of a comprehensive validation report and make any necessary changes to existing documents as a result of report findings.Performance, maintenance and calibration of laboratory analytical instrumentation including.