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Validation Officer (Contingent worker / Temp-to-Hire)
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Description:
Duties & Responsibilities:
- Performing analytical method Validation for Cleaning.
- Performing analytical method Validation for products and method development according to last pharmacopeia.
- 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
Qualification:
- Bachelor’s degree in Pharmacy.
- Minimum Experience: 0-1 years of experience in same field
- Fluency in English, both written and verbal
Location:
Giza, EG
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