R&D Stability Pharmacist (Cairo)
Obour City, CairoPosted 5 years ago294Applicants for1 open position
- 82Viewed
- 3In Consideration
- 245Not Selected
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Job Description
- Participates in Translating business goals into research objectives, plans, and deliverables.
- Coordinates in preparing of activities concerned with analytical method and development of new or improved method of analysis.
- Researches and creates new analysis method of products to be registered and launched onto the market in accordance with regulatory requirements and quality assurance systems under the general supervision of the R&D supervisor.
- Prepares the assessment of summarized experimental data of all investigations pertaining to a product file that is to be submitted for registration.
- Develops and implements method of analysis and development procedures and techniques of analysis of product for DRA
- Prepares the requests needed for new laboratories or laboratory equipment and instrumentation to serve expanding operational requirements.
- Reviews professional journals and scientific papers to keep abreast of changes in processing methods of analysis and stability regulations.
- Prepares & presents the planning and development of survey instruments, guidelines and procedures to collect required data.
- Collect data of stability product and investigation o.o.s
- Ensuring the new product analysis results meet the product specification
- Creates product files & necessary paperwork for registration and export.
- Creates and review SOPs. Of stability and validation.
- Investigates problems relating to products in stability chambers during analysis
- Investigates any out of trend to stability products
- Create and review analytical method validation of new and old product.
- Monitoring & operation of stability unit including of stability chambers operation.
- Conducting stability studies including preparation of stability plans, implementation of the study and related physical and chemical tests as well as preparing final stability reports including analysis of data & findings
- Prepare DRA files and CTD files for export
Job Requirements
- Bachelor's degree in Pharmaceutical science a must.
- 2-4 years of technical experience in process development ,stability ,validation and training preferably in the pharmaceutical industry.
- Scientific, technical background in pharmaceutical as well as cosmetics products is beneficial.
- Using an advanced knowledge of stability and validation guidelines and rules of DRA for registration products.
- Professional in HPLC
