Title:  Methodology Validation Analyst

Duties & Responsibilities:

• Performing analytical method Validation for Cleaning.
• Performing analytical method Validation for products and method development.
• Performing analysis of bulk, semi-finished and finished drug product, if required.
• Chemical and Physical analysis of HIKMA PHARMA and licensors drug product according to the applicable analytical procedure and after having the necessary training.
• Performing instrumental analysis using HPLC, UPLC, Gas chromatographs, UV-Vis spectrophotometer, ICP, IR- spectrophotometers and Atomic absorption spectrometer and other minor analytical equipment after having the necessary training).
• Performing comparative dissolution.
• Performing Method transfer between R&D and QC departments
• Ensures that all obtained results are within the specified approved limit, using a valid method of analysis.
• Immediate reporting of out of specification test results and preparing deviation reports.
• Perform Verification for method validation and performing samples for specific analysis in a specific matrix and making validation for test method.
• Documentation and reporting the analytical results according to the predetermined procedures.
• Preparation of chemical reagents and other required volumetric solution as directed.
• Complying with the occupational safety and waste procedures in Hikma Pharma plant.
• Complying with the applicable GMP standards and procedures after having the necessary training.
• Documentation of analytical results according to the predetermined procedures and reporting events according to the applicable procedures after having the necessary training on the process.
• To perform any other task related to the job description or nature.

Qualifications:

• Bachelor’s degree in pharmacy with grade Very good.
• Minimum Experience: 2-3 years of experience in the same position.
• Ability to work with a team and being an effective team member.
• Fluency in English, both written and verbal