foaud Ali Mahmoud

Quality Assurance SpecialistFull Time

• Job Details:1.Conduct thorough reviews of batch documentation from manufacturing and packaging sites to ensure compliance with regulatory requirements 2. Make informed decisions on batch disposition (release/reject) based on quality control data and cGMP/GDP guidelines 3. Develop and review Annual Product Quality Review (PQRs) reports to identify trends and areas for improvement 4. Verify GMP forms and logbooks to ensure adherence to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) 5. Collaborate with cross-functional teams to resolve quality issues and maintain compliance with regulatory requirements 6. Actively participate in continuous improvement initiatives to enhance quality systems and processes 7. Review and control site Standard Operating Procedures (SOPs) to ensure compliance with regulatory requirements 8. Review master formula cards, specifications, and test methods to ensure accuracy and compliance 9. Review master manufacturing batch records and bills of materials to ensure accuracy and compliance 10. Prepare and review process validation and performance qualification protocols for solid dosage forms. 11. participate in the management of deviations, CAPAs, and change controls, ensuring proper documentation and timely closure. 12. Coordinate sampling plans for validation batches.

Quality Assurance AnalystFull Time

• Job Details:Check machine/line for clearance as per written approved procedures before the start of batch .manufacturing/packaging. . Responsible for manufacturing and packaging cGMP compliance by assurance that both manufacturing and packaging process are in compliance with GMPs including start of runs .In process testing, and inspections. • Reporting the daily IPC activities on daily basis. • Sampling of finished and semi-finished products. . Review and maintain proper documentations and log book and records for products, machines and equipment. . Perform scheduled tours in production area ensuring proper GMP and SOP implementation. . Assist in batch release activities.