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Job Description
- Preparing and issuing 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.
- Coding request for new raw materials
- Assisting in development of some products
- 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 between R&D team and export team regarding export requirements. Preparation and regular update of an excel sheet to record and follow up on R&D action plans executed to maintain export requirements.
- 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 for export 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.
- Attending the tracking the activities of new products committee, through meeting minutes
- Coordination between R&D team, QA department and GxP compliance department to prepare and follow up CAPAs.
- 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.
- General archiving of records and R&D documents.
- 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
- 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.