Qesm Moharam Bek, Alexandria, Egypt
Professional Synopsis: Combining expert knowledge in Pharmaceutical Microbiology with a forward-thinking approach to Laboratory Management. As the QC Microbiology Section Head at Medizen Pharmaceutical Industries, my focus is on bridging the gap between rigorous compliance and modern efficiency. What I Do: I lead teams to ensure the highest standards of Data Integrity and GMP/GLP Compliance. My passion lies in the "Lean Lab" concept—leveraging digital transformation and automation tools like n8n and Docker to streamline microbiology workflows. The Strategic Edge: Currently, I am bridging the gap between scientific precision and strategic management through my MBA research at Alexandria University. I believe that the future of pharmaceutical quality lies in "Management by Data." My goal is to apply business administration principles—such as strategic planning and organizational efficiency—to the technical world of Microbiology, ensuring that laboratory excellence becomes a driving force for overall business growth and operational sustainability. Hamza Science School: Driven by a commitment to continuous learning, I founded Hamza Science School. This project is dedicated to empowering the scientific community by providing high-quality pharmaceutical references and simplified microbiology insights, blending my academic background (M.Sc. & MBA Researcher) with practical industry excellence. Core Competencies: Quality Leadership: QC Micro Management & Manufacturing Oversight. Digital Innovation: Lab Automation, and Workflow Optimization. Education: Technical Training & Knowledge Sharing via Hamza Science School..
Manage all employees in the lab to achieve optimal level, by following their sampling procedures, testing and reporting of all requested samples to be sure that all activities are done with permitted lead time. •Ensure that all employees implement procedure of used equipment and follow validation, qualification, calibration, operation and maintenance of these equipment to have results with high confidence level. •Make sure that all employees apply documentation procedure and all activities are recorded at their exact time to have a system for traceability. •Ensure that all employees attend and pass all on job training courses in order to have authorized qualified analyst. •Ensure that all employees achieve their KPIs to reach their required performance level •Follow with great care the procedures related to cleaning, disinfection, clean room fumigation, appropriate temperature – relative humidity – differential pressure, storage – sub culturing – handling and discarding of microorganisms in order to prevent microbial contamination. •Review standard operating procedures, analytical methods, protocols, trends and approve reports to be in authorized form. •Establish a system for demanding all the needs of the lab considering cost reduction (employees, instruments, microbiological media, micro-organisms tools and chemicals) in order to work at the required level. •Plan and follow the annual quality objective of microbiology for sake of continuous improvement. •Represent the lab towards the internal and external bodies (external auditors, accreditation bodies, sub-contracting production companies, calibration agents, maintenance agents and other companies in Pharco Cooperation) to establish effective communications and Prepare the microbiology lab for external and internal audits in order to comply with audit requirements. •Ensure the implementation of GMP, GLP and ISO rules on practical work and behavior of all employees comply with the latest requirements.
Essential major job duties 1- Prepare and write the relevant quality control documents as SOPs, protocols and technical instructions. 2- conduct routine microbiological analysis of starting materials, packaging materials, bulk and finished products. 3- Validate the microbiology analytical methods. 4- Review microbiological methods. 5- Co-operate in the calibration and maintenance of laboratory equipment. 6- Preparation of microbiological media and reagents. 7- Review results of the microbiological monitoring of water system. 8- Monitor & review results of environmental monitoring program of production areas and microbiology laboratory. 9- Review biological assays for starting materials, bulk and finished products. 10- Review the microbial limit test for non-sterile materials and products. 11- Revive subculture and maintain the standard organisms. 12- Identify the isolates with the different techniques to assist in the investigation of out of specification results. 13- Handle working and reference standards used for antibiotic assay. 14- Ensures the Monitoring of the retention of the QC records. 15- Participate in OOS & OOT investigation in microbiology laboratory. 16- Check the Laboratory organization (For example; document, glassware, chemicals and equipment). 17- work according to cGMP rules and pharmacopoeial guidelines. 18- Authorized as backup person in case of Microbiology Section Head absence.
preforming and supervising all pharmaceutical microbiological testing requirements and documentation that may include -not limited- the following : - Implement cGMP and GLP standards in the laboratory - Review microbiological test results to ensure that specifications are met accordingly. - Provide training for new hired analysts and technicians. - Create and update SOPs and testing method validation and verification protocols. - Conduct OOS and OOT investigations. - Design plans for non-routine investigations. - Report trend analysis of microbiological data quarterly (if any) to QC and QA managers -Ensures the transfer, application, qualification and validation of microbiological methodologies for, in-process & QC batch release and stability testing of a wide range of potential pharmaceutical products. -Follow-up the microbiological analysis of finished products as well as starting materials according to USP & EU Standards. -Monitor the water station and water for production -Monitor the hygiene sanitation and the environmental conditions of the factory -Regards Industrial Hygiene and monitors Lab Analysts exposure to Hazards. -Follow-up the Industrial Hygiene and ensuring the cleanliness of Plant. Reviews daily reports and prepare monthly & Quarterly performance reports. Defines problem areas concerning system conflict and design the appropriate countermeasure. Works cross-functionally to resolve issues & discrepancies and to develop any preventive actions to secure the products from any incidents that may cause product turning back, recall or even client's complaints. Prepares & develop work procedures. Follow-up the calibration & Validation of different equipments in Microbiology Lab. - follow up the stocks and requirements of the lab and follow the purchasing process - Check working performance of analysts and technicians to ensure instructions are followed accordingly.
private and volunteer science,biology,chemistry and physics teacher teaching all levels from junior 4 to senior 3 in Arabic and English also teaching for IGCSE, SAT and American diploma students
maintenance of all computer requirements software ( windows,drivers and programs ) and their related issues hardware (screens, boards and printers ) at small scale and under supervision Network ( implementation of networks and maintaining its problems )