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.
Bachelor Degree of Pharmacy is a must & (Master’s degree is a plus).Strong background in pharmaceutical raw materials, excipients, and APIs.Minimum 8–10 years of experience in pharmaceutical R&D, with at least 3–5 years in a supervisory/leadership role.Proven experience in evaluation, characterization, and qualification of raw materials.Pharmaceutical Industry Experience is a must.Excellent knowledge of pharmacopeias (USP, EP, BP, JP) and ICH guidelines.Hands-on experience with analytical techniques (HPLC, GC, FTIR, NMR, etc.).Strong understanding of raw material compatibility, functionality, and impact on formulation development.Knowledge of GMP, GLP, and regulatory requirements for raw material approval.Familiarity with risk assessment and vendor qualification processes.Strong leadership and team management capabilities.Effective communication and reporting abilities.High attention to detail and commitment to data integrity.Continuous learning mindset to keep up with new raw materials and technologies.