Eman Ahmed Hassan

QA directorFull Time

• Job Details:A. QA Responsibilities: 1. Management and oversight of all quality related activities 2. Ensure appropriate implementation and maintenance of GMP/GDP Quality systems in compliance with both regulatory and company requirements by: - Implementing quality systems in accordance with applicable company quality standards - Elaborating a documentation system based on company quality procedures - Implement and drive a risk management system 3. Handling of deviation, complaint, change control, CAPAs systems 4. Manage in coordination with global functions critical issues like product alert, recall, withdrawals 5. Manage quality aspects of storage, distribution and cold chain for the region including: - qualification of storage, distribution and cold chain following current international GDP guidelines - Reporting and handling shipment T° deviations - Shipment T° assessment and release 6. Assure inspection readiness of regional activities 7. Coordinate and follow up Health Authorities inspections and related CAPAs 8. Manage all quality related aspects of GxP vendors (e.g.: distributors, CMOs) including: - Qualification, approval and establishment of Quality agreements - Elaboration and execution of audit program - Review and follow up of related CAPAs until closure - Handling of quality issues with the vendors (e.g.: quality deviation, complaint) - Perform batch disposition of products manufactured by CMOs in compliance with Marketing Authorization (if applicable) - Review and approve major changes 9. Define an internal audit program and ensure that audits are performed and related CAPAs followed and closed 10. Assure that personnel involved in GMP/GDP tasks are trained and qualified 11. Implement and execute Quality Management Reviews 12. Foster a culture of quality within the organization 13. Inspection of warehouses and distribution centre to assure Good Storage Practice, Good Distribution Practice and control of dispensing process of raw and packaging materials B. PV Responsibilities: 1. Create and maintain Local SOPs for Pharmacovigilance. 2. Conduct training on adverse events reporting. 3. Conduct Pharmacovigilance management monitoring as per the annual plan, identifying gaps and developing CAPAs 4. Responsible for Audit preparation