Eslam El Aila

 SME of Suppliers Management System, and responsible for: • Quality agreements system with suppliers of materials/services. • Suppliers’ qualifications process including supplier’s notifications control and supplier’s risk assessments. • Request and Review Suppliers audits ratings and CAPAs progress. • Create, review, and approve supply channels for supplied Materials/Services. • Handling of Material certifications documents “Including BSE/TSE” for supplied materials.  Quality Management System: • SME of QC SAP system. • Initiate, Review and Approve Quality reports through Quality Tracking system: (Laboratory Investigation Reports (LIRs) - Quality Assurance Reports (QARs) - Change Control Reports (CCRs) - Commitment Tracking Modules (CTs) - And Supplier Corrective Action Reports (SCARs), whenever required. • Attend and participate in internal/external audits. • Initiate, Update, Review, and Approve required documents for quality (ex: SOPs, RASs, Protocols, reports, …. etc.).  People management & Routine work of Incoming materials: • Coach, follow up, and control colleagues’ tasks in the section; and encourage them to initiate innovative projects and improvements. • Building Successors and backups. • Planning the daily schedule for section colleagues’ tasks. • Responsible for release of materials through SAP system with considering of FIFO concept and planning requests. • Identifying and work on section needs (ex: New Instruments, calibration and maintenance, consumables, … etc.).  SME of Artwork System: • Plant Artwork coordinator responsibility for Artwork updates’ reviewing and approval through Artwork system, including communication with Regulatory, production and Supply chain teams. • Review / Approve packaging materials specs based on updated artworks.

Suppliers Management System: • Responsible for Quality agreements system with material’s Suppliers. • Responsible for Suppliers qualifications system including supplier’s notifications control and supplier’s risk assessments. • Request and Review Suppliers audits ratings and CAPAs progress. • Ensure that the exact supply channels are created, reviewed and approved for each supplied material. • Request, review and approve Material certifications documents from materials vendors. Incoming materials (APIs & RMs): • Planning the daily schedule for section colleagues. • Responsible for release of materials through Pfizer global system. • Participating in Data Integrity implementing in Pfizer Egypt as per internal guidelines and FDA CFR part 11 guidelines. • Initiate, review and approve: Laboratory Investigation Reports (LIRs), Quality Assurance Reports (QARs), and Change Control Reports (CCRs) whenever required. • Initiating and updating of required SOPs and Protocols. • Identifying section needs regarding instruments, maintenance, reagents and system areas which need improvement. • Following up and control colleagues’ tasks in the section and encourage them to initiate innovative projects and improvements.

• Sampling, testing and documenting results for all incoming /retest items. • Reviewing analysis results generated by other colleagues. • Control and review of Instruments Calibration in raw materials section. • Control, Request required consumables and update the related Inventory. • Participating in Suppliers’ qualifications system.

• Create, develop, and validate analytical test methods of different forms of pharmaceutical products according to ICH, pharmacopeia and WHO guidelines. • Creating the Biowaiver studies and comparative dissolutions profiles reports according to FDA guidelines. • Full analysis on R&D trial samples. • Analysis of stability samples and creating studies reports for each long term & accelerated Conditions according to ICH, FDA and WHO guidelines. • Preparation required files and reports for MOH authorities.

• Perform all required testing analysis “Physical and Chemical tests” for different products forms (ex: Tablets, HGCs, Soft GCs, Syrups, suspensions, POS, Ointments, Creams and Ampoules).