• Quality Assurance unit head (Documentation ,IPC, internal auditer, valid. and Calib. official)
ميباكو -ميدى فود
مجموع سنوات الخبرة :12 years, 7 أشهر
• Documentation officer & internal auditor:
- Participate in preparation of work systems documents in the company (Quality - Environment- Safety & Occupational Health-Food Safety and GMP).
- Distribute documents to its use sites and follow-up distribution records.
- Withdraw the obsolete documents and prepare record for that.
- Save requests (issue / modify / cancel) documents.
- Prepare the key list of documents and update as needed.
- Review the company documents in various departments in its use sites and match with the original version in Quality Assurance management.
- Save backup copies of the documents on CDs/ distinctive discs (if possible).
- Save and maintain the original copy of the documents.
- Participate in the preparation of the annual plan of internal audits (Quality/Environment/Safety and occupational health…….).
- Participate in the implantation of internal audit plan as internal auditor.
- Follow-up & Save the reports of non-conformity of each audit (in the audit file for each system (Quality - Environment- Safety & Occupational Health-Food Safety and GMP.).
- Follow-up the responses of departments to case of non-conformity and follow-up the implantation of the proposed corrective actions until the closure of these cases.
- Follow-up of customer compliance and recall system.
- Follow-up of change controls &deviation reports.
- Save and maintain the records and results of internal & external audits.
- Follow-up external audit file and the resulting non-conformity cases or recommendations.
• Validation officer :
- Share in prepare of all qualification with Engineering Department.
- Prepare all validation (Process, method, cleaning, hold time study, Environmental mapping) protocols and reports.
- Step by step review executive of all types of validation (Process, method, cleaning, hold time study, Environmental mapping) and qualification during validation runs.
- Share in prepare the final approval of all process changes needed during the course of validation prior to implementation.
- Investigation of all process deviations and any OOS (out of specification) results encountered during the validation runs and its documentation.
- Save and maintain the original copy of the documents.
• Calibration official at Mepaco-Medifood:
- Review all Equipment lists in production, quality control, R&D, Ware house & Quality Assurance Department.
- Make calibration plan for all Instruments & Equipment in Plant (quality control, R&D, Engineering, and Production & Ware House) departments.
- Implement internal &external Calibration to all Instruments in the plant.
- Issue and review the calibration certificates.
- Make Monthly report to make data analysis.
- Perform of calibration of masses and all load cells or stain gauges as balances, hardness and torque.
- Perform of calibration of all types of pressure gauges.
- Perform of calibration of all type of thermometer or data loggers and all studies for thermal or humidity as mapping or room's verification.
- Perform of calibration of RPMs, timers, counter gauges, lengths, Volumes.
- Trained to Perform of qualification for LAFs and HVAC system.
• Training coordinator for student summer training:
- Receive universities notification for student training.
- Preparing students list and dividing them into groups.
- Preparing the training plan.
- Notify relevant departments of the plan.
- Notify the trainers of the plan.
- Receiving of students and following up the implementation of the training process
- Student evaluation.
- Issuance of training certificates to the student.
- Distribution of evaluation records and certificates to students.
- Save and maintain the records.
• Assuring the application of cGMP procedures in the production areas.
• Assist QA team in batch documents review & release
• Prepare of samples and documents submitted to the MOH inspectors.
• Trained on solid preparation line (Tab preparation) and All IPC Activities (Granulation, Drying, Sizing, Compression tablet, Coating, Striping) in solid dosage form department at Mash Pharma.
• Trained on syrup preparation line, filling, packaging &All IPC Activities
• Member in validation team for both process and cleaning validation.
• Perform the required IPC analysis e.g.: average weight, moisture content, disintegration, hardness, friability, pH, conductivity, leakage, torque testing.
• Trained on ( sterilization & disinfectant process, microbial control, microbial environmental control, TBC, TFC & Microbiological assay)
• Trained on how the water station work (design, sampling points, and analysis of the sampled according to specs).
• Trained on (cGMP, warehouse IPC officer, Production IPC Officer, Self-inspection, Risk management CAPA system, validation system & Calibration) at waki pharm.
• Documentation Officer (document control, Record control, Batch creation & release, SOP Creation, coding system) & training Coordinator
إستقبال المواد الخام من المورد بعد تحليلها ومتابعة سير العمل حتى تسليمها كمنتج تام إلى العميل
سحب وتحليل العينات بأقل وقت ممكن وبدقة عالية
Bachelor of Science (Microbiology Section) Faculty of Science, Al-Azhar Univeristy Final year grade: Good (70.57%) Graduation project: Archaea bacteria