Methodology Analyst At APEX Pharma
Location: Badr City, Cairo
Method Development and Optimization: design and optimize analytical methods for the characterization, identification, and quantification of pharmaceutical products.
Validation of analytical method: establish and validate robust analytical methods to ensure the quality, purity, and potency of pharmaceutical products.
Preparing of NODCAR files.
Ensure compliance with relevant regulatory requirements and guidelines.
Conducting the comparative dissolution studies.
Analysis of R&D trials.
Implementation the high-quality standards and GLP requirements.
Bachelor’s degree of pharmacy or science (chemistry).
3-5 years of experience in similar position (males are preferred).
Strong knowledge of development processes, regulations, and quality control practices is essential.
Familiarity with regulatory guidelines such as (FDA) and (ICH) guidelines (is important).
Proficiency in a wide range of analytical instruments commonly used in the pharma industry like (HPLC, GC, UV-Vis, and dissolution tester).
Experience with method development, validation, and transfer.