Perform testing and decide on the acceptability of the in-process, process validation samples, finished products, stability samples and developmental samples in a regulated laboratory environment. Analyze and interpret results in written and oral format.
· Perform routine tests of finished product and stability samples including dissolution, assays, chromatographic purity, content uniformity using UV and HPLC, particle size distribution using different techniques including Light Scattering (e.g. Malvern), density, water determination by KF, and tests according to the in-house monographs and USP in a regulated laboratory environment.
· Evaluates test results and decides acceptability of the samples based on the test results.
· Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs.
· Maintain the laboratories with good housekeeping practices and in compliant with cGMP.
· Ensure notebooks are reviewed in a timely manner, in accordance with SOPs.
· Design and develop test methods, perform experimental tests and evaluate performances.
· Write test methods, method validation protocols and reports.
· Establish test specifications and communicate with internal and external customers.
· Analyze and interpret results in written and oral format.
· Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment
Bachelor’s degree in Chemistry or related scientific field and 2+ years related experience in pharmaceutical analysis OR Master’s degree in Chemistry or related scientific field and 1+ year related experience in pharmaceutical analysis.
To perform this job successfully, an individual should have: