Validation Officer At Hikma Pharmaceuticals
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.
Preparing & executing process validation protocols & process validation reports.
Environmental monitoring reports/trends review.
Follow up implementation of calibration system.
Performing equipment’s qualification, calibration and preventive maintenance.
Qualifications:
Bachelor’s degree in pharmacy with grade Very good.
Minimum Experience: 0-1 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
Location: Giza, EG