مطلوب صيدلي ابحاث لدى شركة الحكمة للادوية

Job description:
Job Specific Accountabilities:

• Implements injectable product development activities including project initiation, study designs, routine laboratory procedures, and reports preparation to support product development efficiently.
• Knowledge on injectable process development aspect such as compounding, filtration, filling operation and terminal sterilization by autoclaving required.
• Understanding on pharmacopeial requirement & ICH guideline for parenteral dosage forms.
• Aware about principle of QbD (Quality by Design) for product development and DoE (Design of Experiment).
• Documentation preparation experience on Tech Transfer Report, Product Development Report, setting product specification and Risk assessment required.
• Knowledge of filter, tube and packaging material selection, filter validation, extractable and leachable study.
• Analyses and evaluates test results to make well-reasoned strategic recommendations that inform future R&D decisions at Hikma.
• Summarizes and critically evaluates the study results, trend analysis, stability monitoring, trouble shooting in order to develop and test new hypotheses, execute experiments and author technical reports.
• Demonstrates excellent oral and written communication skills with ability to present results through written reports, publications and related documentation.
• Participates in the development and scale-up processes from bench top to pilot scale in order to assist in technology transfer to commercial plants.
• Gathers and provides new perspectives, arriving at solutions based on multiples sources of information to evaluate and solve complex technical challenges that arise on both internal and external projects.
• Collaborates and gains commitment with stakeholders internally and externally to achieve project objectives in support of product development and approval.

Minimum Qualifications:
 

Bachelor’s or Master’s degree in Pharmacy .
 

Minimum Experience:
 

3-5 years of experience in the pharmaceutical industry with a Injectable R&D focus preferred

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