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Possess thorough knowledge and experience of various laboratory instruments like, but not limited to, HPLC, UV/VIS, Dissolution, FTIR KF, Polarimeter, TGA, etc. Trained on cGMPs/SOP/Safety Guidance extensively. Able to troubleshoot instrument and/or method related problems efficiently. Strong computer application skills with knowledge of chromatographic data system (CDS). Tested scripts for IQ/OQ/PQ of the Empower upgrade process. Able to independently develop and validate analytical method(s) for new products/drug substance/cleaning in tablet, capsule/pellets dosage forms and improve existing method(s) for greater method efficiency. Worked closely with USP Liaison to establish the in-house Method Equivalency to align with USP method once the Monograph becomes official. Trained in WISDOM and Trackwise as a group representative to support the lab function and Change Control. Have written Protocols & Test Procedures, Validation & Stability Report.

Listed skills include Dissolution, Validation, Gmp, Hplc, and 17 others.