Conducting activities related to drug development process which includes:
Basic literature survey to assure development capabilities; technical evaluation, and preparation of bill of materials.
Reference product physical and chemical characterization.
Extensive literature survey, including full research for all the needed information regarding drug product method of development.
Participating in the design of pre-formulation studies, optimization studies, and performing small-scale trials and taking decisions upon results analysis.
Performing scale up (pilot) batches and related activities in Amman.
Following up with the analysis department to observe the projects development within the due timeline.
Preparing Technology transfer documents for Tabuk manufacturing sites:
Preparing Bill of Materials (BOMs), Process Operation Instructions (POIs), Process Validation Protocols (PVPs) & Stability Protocols (SPs) for the required molecules.
Preparing detailed technology transfer report that summarize all the history of the trials, results, the critical quality attributes and the related control process parameters (Based on Quality by Design approach).
Preparation of CTD documents for registration files:
Creating the CTD documents that are related to the R& D work.
Responding for technical deficiencies.
Renewal related work.
Variations related work.
Technical support for MENA regulatory affairs:
Preparing the required technical documents.
Preparing Process validation protocols for different authorities and manufacturing sites.
Preparing stability protocols for different authorities and manufacturing sites.
Transfer of Technical experience to different manufacturing sites.
R&D Documentation system:
Complete and proper documentation for R&D batches.
Revising R&D documents such as POI and PVP based on any required updates in the process, specification or guidelines
Proper documentation for R&D documents; POI, PVP, PVR, reports, SOPs, etc.
