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Job Description
- Job Responsibilities:
- Assure that the New Pharmaceutical Products are well developed.
- Responsible for improvement of already Formulated Products takes place regularly & prepares the pharmaceutical products that will be produced to be developed.
- Responsible for the selection of the critical raw materials suppliers, following up test of analysis to ensure the safety, the quality of the samples & comply with the new, produced or developed products. Follow up the material supplies after analysis, accept or reject the materials according to the defects & obligate the in cases of non-conformity to replace the materials in specific lead time that will not affect the production process.
- Follow up raw materials suppliers “Contractors or non-contractors”& the supplies needed & comply that with the research & production plan in coordination with the related departments in the company.
- The Product Samples for regulatory affairs are prepared according to the product design without any violations & complied with the company designs.
- The Manufacturing Formulae and processing Instructions are well prepared and revised.
- The Packaging Instructions are suitable for each Pharmaceutical Product.
- Technology Transfer Report is clear and legible.
- Scaling-up to production area is successful.
- The Sampling Plan for validation batches of different Pharmaceutical Products is effective.
- The 1st, Three Produced Successive Batches (Validation Batches) of different Pharmaceutical Products, with production personnel are successful.
- Trouble-shooting in production, if any, is overcome.
- Comparing Different Formulations, for the same Pharmaceutical Product, during the Pharmaceutical Products' development and upon storage, is performed to choose the proper formulation for each Pharmaceutical Product.
- New Products are properly selected.
- Registration, Re registration & export Files are well prepared.
- Ministry of Health requirements for the Pharmaceutical Products under registration are completed at the specified time.
- Maintain the confidentiality of data & company documents in R&D, get the approval from the R&D manager & managing director to copy, scan or send any document to internal or external authorities.
Job Requirements
- Master degree in pharmaceutics or industrial pharmacy as a minimum.
- Not less than 10 years of experience in Product development.
- Acquainted with the concept of quality by design and CTD files preparation.
- High team leading skills and very good communication skills.
- High efficiency in time management and ability of leading several projects in parallel.