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Job Description
- Preparing and issuing Preliminary and draft of API, Excipient, and Packaging material specifications of Pharmaceutical Products according to current guidelines and supplier certificate of analysis in cooperation with R&D team.
- Revision of certificates of analysis of raw materials received from supply chain department and ensuring it is as prepared raw material specifications.
- Review of Supplier documents on Ampelogic vendor Qualification module .
- Assist in receiving, archiving Drug Master file (DMF) upon request.
- Preparation and regular update of follow-up documents to record the status of New Pharmaceutical Products, products undergoing redevelopment, list of products awaiting APIs, list of products awaiting brand and other follow up sheets required by R&D manager.
- Coordination with R&D team and other department for the technology transfer and preparation of new pharmaceutical products for production though new products committee.
- Preparation of technical documents required by R&D department as elemental impurity risk assessment, and pharmaceutical development report upon request of R&D manager.
- Data gathering, related statistical analysis and preparation of the Quarterly presentation of R&D department to be presented in MCM meeting to Managing Director.
- Oversees the document validation and organization and make sure that it is available to appropriate people and systems within the company.
- Scanning, uploading, or filing of research documentation related to assigned activities and ensuring documents are properly backed-up.
Job Requirements
- Bachelor degree of Pharmacy or Science.
- Experience from 1 : 3 years in Research& Development Field or Raw material field .
- Pharmaceutical background is a must
- Excellent Communication & Organization Skills .
- 6th October City residents or nearby are preferred.
