Job Description

Duties & Responsibilities:

1. Method development for the new products.
2. Performs analysis of method validation for new products & re-registration.
3. Complying with the occupational safety and waste procedures in Hikma plant.
4. Complying with the applicable GMP standards and procedures after having the necessary training.
5. 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
6. Performs second person verification of AR products analytical results.
7. Revision of the AR section in the process validation protocols.
8. Data recording & revision for AR results.
9. Preparation & revision of registration & re- registration documents.
10. Performs analysis of bulk, semi-finished and finished drug product, if required. Chemical and Physical analysis of HIKMA QUALITY and licensors drug product according to the applicable analytical procedure and after having the necessary training. (If required)
11. Performs instrumental analysis using HPLC, Gas chromatographs, UV-Vis spectrophotometer, IRspectrophotometers and Atomic absorption spectrometer and other minor analytical equipment after having the necessary training). (If required)
12. Distribution of daily tasks for AR team members, follow-up and supervising the completion of tasks and evaluate the whole analysis processes.
13. Communication with other departments to facilitate work flow.
14. Preparation of SOPs related to instruments and working System.

Qualifications:

• Bachelor’s degree in Pharmacy or Science with grade Very good or Excellent
• Minimum Experience: 0-2 years of experience in same field
• Fluency in English, both written and verbal