Perform validation of new developed methods of analysis and full analysis of new products or currently produced products whenever required.
• Collect the data and literature review for the compound under analysis to develop a method of analysis for the new products.
• Perform revalidation of the methods of analysis for re-registration or when required to comply MOH requirements.
• Perform full analysis of the developed trials and report the physical and chemical observations of the trials, to draw potential conclusion on these trials.
• Identify quality problems and recommend solutions.
• Perform method transfer of validated analytical methods to quality control lab and stability lab (according to Analytical Method Transfer SOP) as a part of lab to lab reproducibility.
• Perform the validation of the comparative dissolution study of the production batches (in case of formula variation, new suppliers, re-registration and new products) to comply MOH requirements.
• Calibrate or verify calibration, maintenance and cleaning of methodology lab instruments to comply good laboratory practice (GLP) guidelines.
• Assist in writing technical reports or documentation, such as deviation reports, method transfer reports and out of specification reports.
• Compliance with current MOH regulation decrees, guidelines in pharmaceutical industry and cGMP regulations
Bachelor of Pharmaceutical
Years of Experience:
21 March 2021
Application End Date:
21 April 2021
R&D - Methodology