Maha Mohamed Medhat

• Internal audit and self-inspection process
• Handle and manage site quality issues related to site compliance performance
• Leading QMS policies deployment and assure their effective implementation
• Participate in annual quality strategy and objective
• Follow up of key policies handling (Deviation handling, customer complaints, recall, nonsterile operation and validation)
• Act as change control process management for planned changes and review their effective implementation
• Ensure proper lifecycle management of documents
• Monitor all operations that affect quality
• Approve all SOPs before issuing
• Determining training needs & follow up technical training plan execution
• Approve calibration plan and follow up the plane execution
• Approve all validation protocols and validation reports
• Approve proper action for nonconformities which taken by concerning department and assuring that the all NCRs & CAPA has been done in proper time& being closed
• Ensure proper maintenance of all department & equipment are done properly
• Approve the newly issued batch record
• Discussed the results of internal audit & supplier audit with the top managements

• Internal audit and self-inspection process manager
• Handle and manage site quality issues related to site compliance performance
• Leading QMS policies deployment and assure their effective implementation
• Participate in annual quality strategy and objective
• Follow up of key policies handling (Deviation handling, customer complaints, recall, sterile operation and validation)
• Act as change control process owner for planned changes and review their effective implementation
• Insure proper lifecycle management of documents
• Monitor all operations that affect quality
• Approve all SOPs before issuing
• Determining training needs & follow up technical training plan execution
• Approve calibration plan and follow up the plane execution
• Approve all validation protocols and validation reports
• Approve proper action for nonconformities which taken by concerning department and assuring that the all NCRs & CAPA has been done in proper time& being closed
• Ensure proper maintenance of all department & equipment are done properly
• Approve the newly issued batch record
• Discussed the results of internal audit & supplier audit with the top managements

• Internal audit and self-inspection process manager
• Handle and manage site quality issues related to site compliance performance
• Leading QMS policies deployment and assure their effective implementation
• Participate in annual quality strategy and objective
• Follow up of key policies handling (Deviation handling, customer complaints, recall, sterile operation and validation)
• Act as change control process owner for planned changes and review their effective implementation
• Insure proper lifecycle management of documents
• Monitor all operations that affect quality
• Approve all SOPs before issuing
• Determining training needs & follow up technical training plan execution
• Approve calibration plan and follow up the plane execution
• Approve all validation protocols and validation reports
• Approve proper action for nonconformities which taken by concerning department and assuring that the all NCRs & CAPA has been done in proper time& being closed
• Ensure proper maintenance of all department & equipment are done properly
• Approve the newly issued batch record
• Discussed the results of internal audit & supplier audit with the top managements

• Validation & Risk Assessment
• Responsible for Audit readiness

Lead all Quality Compliance activities includes:

Handling of Deviation

Risk Assessment

Corrective and preventive action

Risk Assessment

Audit readiness

Responsible for IPC team in (Solid Dosage form- Semi Solid dosage form- Softgel Dosage form)

Responsible for conducting and reviewing APQR

Responsible for batch record review

Working In documentation Section

Responsible for revision of distribution of technical documents and procedures

• Educated patients about possible drug interactions and gave special administration instructions.
• Collaborated with pharmacy team members to develop and implement strategies for continuous improvement in quality of care.
• Managed high volume of prescriptions daily while maintaining excellent customer service and attention to detail.
• Conducted regular audits of the hospital department's controlled substances inventory, ensuring accurate record-keeping and preventing diversion or theft.

In process Control Specialist in Different Dosage forms:

Solid- Semi Solid- Soft Gelatin

Conduct APQR

Conduct routine IPC tests

Assure Compliance of cGMP in different production and Packaging departments

Sampling of IPC and finished goods samples