Department:Research & Development

Location:Alexandria

Job ID:PH-RES-ME

Methodology Specialist

Summary:

Perform validation of new developed methods of analysis and full analysis of new products or currently produced products whenever required.

Job requirements:

• 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 

Qualifications:

Bachelor of Pharmaceutical 


Years of Experience: 0

Posting Date: 21 March 2021

Application End Date: 21 April 2021

Available Vacancies: 2

Job Level: Specialist

Function: R&D - Methodology

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