Kareim Ibrahim Hassanin

QC managerFull Time

• Job Details:QC Manager - Quality Control Department: Supervise and approve the following activities: o Starting materials release. o Finished and bulk products release. o Cleaning validation and cleaning method validation. o Stability analysis of finished products. o ISO and GMP training. Validation of the main plant utilities: o Water production and distribution system. o Pure steam production and distribution system. o Nitrogen and production and distribution system. o EM qualification and monitoring of micro lab and sterile area. Nov

Quality ManagerFull Time

• Job Details:• Responsibilities: -Creation, implementation and maintaining of Quality Management System according to ISO 17025. -Application for EGAC accreditation for ISO 17025 (Pending project). -Revision and approval of the technical documents according to guidelines and standards

QC supervisorFull Time

• Job Details:• Responsibilities: - Backup person for QC Manager. -Supervision of the following activities:  Reference standards and reagents control.  Starting materials sampling.  Starting material analysis.  Finished and bulk products analysis.  Cleaning validation and cleaning method validation.  Stability analysis of finished products.  ISO and GMP training. -Analysis of Starting material analysis (including Raw and Packaging Materials). - Handling and receiving of chemicals and reference standards and working standards. -SOPs Creation and Handling (General, Instruments, Monographs, Specifications, etc…). -Handling of quality audits from multinational companies (Pfizer, GSK, Novartis, Sanofi Aventis, Roch, Ranbaxy) and local companies (such RAMEDA, Hope Pharma). - IPC in sterile production areas. - Training of new analysts and trainee. -Validation of the main plant utilities:  Water production and distribution system.  Pure steam production and distribution system.  Nitrogen and production and distribution system