R&D Raw Material Section Head

1-Preparing and reviewing preliminary specifications of APIs, Excipients and Primary Packaging materials related to new products requirements and releasing PRs related to them.

2-Revision of certificates of analysis of raw materials received from supply chain department against raw material specifications and pharmacopeia monographs.

3-Negotiation with suppliers to solve problems related to pre-shipment COAs not completely matching R&D specifications.

4-Document review on vendor qualification system of 15 items per month for both new materials and existing materials from new suppliers.

5-Coordination with supply chain department to receive R&D requirements for new products in time (products per month)

6-Preparing, reviewing and issuing raw material specifications of APIs, Excipient, and Primary Packaging material specifications of Pharmaceutical Products according to current guidelines and supplier certificate of analysis in cooperation with R&D team.                                                    

7. Assisting in development of some products                       

8. Coordination with R&D team and other department for the technology transfer and preparation of new pharmaceutical products for production though new products committee.

9. Preparation of technical documents required by R&D department for export as elemental impurity risk assessment, residual solvent risk assessment and nitrosamine risk assessment (as per nitrosamine risk assessment plan.

10-Ensuring that drug master files are reviewed and approved and sent to QA department 

11-Oversees the document validation and organization and make sure that it is available to appropriate people and systems within the company.