Job description:
Duties and Responsibilities:
- Method development for the new products.
- Performs analysis of method validation and stability for new products & re-registration.
- Enter and flow up the stability products for all stability conditions.
- Complying with the occupational safety and waste procedures in Hikma 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
- Performs second person verification of AR products analytical results.
- Revision of the AR section in the process validation and stability protocols.
- Data recording & revision for AR results.
- Preparation & revision of registration & re- registration documents.
- Performs analysis of bulk, semi-finished and finished drug products, if required. Chemical andPhysical analysis of HIKMA QUALITY and licensors drug product according to the applicable analytical procedure and after having the necessary training. (If required)
- Performs instrumental analysis using HPLC, Gas chromatographs, UV-Vis spectrophotometer, IR- spectrophotometers and Atomic absorption spectrometer and other minor analytical equipment after having the necessary training).
- Review chemicals stocks and order offers of spare parts, maintenance, external calibration and Qualification.
- Preparation of SOPs related to instruments and working System.
Qualifications:
- Bachelor's degree in Pharmacy or Science with grade Very good or Excellent
- From 0-2years of experience in the related position
- Fluency in English, both written and verbal
