R&D Assistant Manager
TPRC
Total years of experience :23 years, 4 Months
My work consists of the following:
1. Conduct an Internal Audit of the different sections.
2. Monitoring Bioequivalence Studies.
3. Ensure the full compliance of the laboratory with cGLPs by updating the system and SOPs to align
with the updated regulations and guidelines.
4. Handling the Development of the analytical procedures to be followed in the testing of
products under development and later in Quality Control.
5. Handling the Qualification of all the Laboratory equipment.
6. Handling the calibration program for all the laboratory equipment as per the set SOPs.
7. Establishment of Raw Materials, In-process and Finished products specifications, and test
procedures according to the pharmacopeia and ICH guidelines to be in line with SFDA and
authority requirements.
8. Provide management supervision and technical training to all laboratory employees.
9. Handling the analytical methods transfer (TAP) for the quality control Departments in different
company manufacturing sites to ensure smooth and practical implementation of the test
procedures.
10. Leading the analytical validation section for the complement of validation of all analytical
procedures as per the updated pharmacopeia and guidelines.
11. Follow the new product stability programs to ensure the stability of the products before registration.