تعلن Tabuk Pharmaceuticals Manufacturing Company في الاردن عن حاجتها الى :
Formulator
Job Description
- 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.
- Maintaining general cGMP requirements in R&D.
Qualifications & Experience :
Bachelor degree of pharmacy with experience of 2-3 years only.