القائمة الرئيسية

الصفحات

وظائف شاغرة للصيدلة لدى شركة تبوك لصناعة الأدوية في الاردن

 


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.


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