Elham Mabrouk Mohamed

Quality Assurance- Validation &Risk Management LeadFull Time

• Job Details:Responsible for follow up& Handling all activities related to validation department and validation team Responsible for the implementation and maintenance of validation master plan. Preparation and reviewing of validation protocols and reports. Review/assess proposed changes to validated processes via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status Provide technical support in resolving validation‐related exceptions or deviations. Provide validation‐related technical assistance to all the departments. Preparing annual process and cleaning validation plan. Reviewing and approval of cleaning validation protocol and report for each worst case. Perform a wide variety of activities to ensure compliance with quality systems, quality procedures and applicable regulatory requirements. Develop, implement and maintain programs and processes to ensure compliance with Current Good Manufacturing Practices (cGMPs). Review the master manufacturing batch records before its issuing Participate in verification of quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained /controlled Interface with regulatory agencies as required. Preparing and approval of all QRM plans and reports. Prepare the QRM study protocol in co‐operation with QRM team Monitoring the implementation and compliance with Good Manufacturing Practice principles through conducting two periodical self‐inspection ,one audit for quality management system and the other audit for environmental management system & OHS management system) then issuing an auditing report Quality Risk Management Committee Editor: Responsible of QRM committee meetings Preparing of QRM policy, SOPs and plan. Validation Committee Editor Responsible of Validation committee meetings

Quality Assurance- Validation SpecialistFull Time

• Job Details:Validation processes follow up for all pharmaceutical products by preparing annual validation plan, sending validation notification for each product and follow up its validation process. Issuing of validation protocol and report for each pharmaceutical product. Issuing of Master Formula for each product after its validation completion. Reviewing of all Batch Manufacturing Record for all the validated products. Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained /controlled Responsible for internal personnel training of Quality Assurance Directorate Receiving monthly training plan & unplanned training courses or seminar from training department and make Election& Excuse for all QA Directorate Personnel accompanied by training efficiency sheet. Follow up On job training for all QA personnel Receiving course's results and record training courses for each employee in training record and keep copy of certificate in each employee file.