Mostafa Ibrahim Ramadan

Quality Assurance SpecialistFull Time

• Job Details:Develop, implement, and maintain quality assurance policies, procedures, and documentation systems. Ensure compliance with international regulatory standards (e.g., GMP, ISO 13485, FDA 21 CFR Part 820). Monitor and verify quality activities throughout manufacturing and packaging processes. Perform review and approval of batch production records, deviation reports, CAPAs, and change controls. Participate in internal audits and external inspections; support audit readiness and follow-up actions. Assist in qualification and validation activities for equipment, processes, cleaning, and utilities. Analyze quality data, identify trends, and recommend improvements to enhance product and process quality. Investigate non-conformances and implement root cause analysis and corrective/preventive actions. Ensure proper documentation practices are followed according to GDP (Good Documentation Practice). Support training programs related to quality systems, GMP compliance, and operational procedures.

Quality Assurance IPC SpecialistFull Time

• Job Details:Make sure that all production processes are being performed in compliance with GMP. -Ensure that all processes running inside their holding times. -Ensure the room/line clearance before start with the production process. -Ensure the necessity sample testing to confirm safe cleaning process, as per the written SOPs and assure that all machines and equipment are identified. -Verify all IPC instruments to ensure cleaning and the accuracy of its readings before proceeding with the production. -Check the batch processing record before start with the production process and keep reviewing the batch record during the production process. -Make sure of keeping all tests results in the batch production record. -Keep the in-process quarantine contents. -Environmental condition monitoring. -Sampling of all cleaning samples (chemical and physical and microbiological) and delivered them to Q.C laboratories. -Sampling of all processing samples according to related SOPs and delivered to QC laboratories. -Perform all activities related to ERP system for all stages of production (Material Issues for all stages, WH transaction for all stages, all tests' samples inputs, product calculation reviewing and conformation before dispensing, finished product reviewing, all returns reviewing in all stages, function tests results, all dispensing materials adjustments, all dispensing materials re-open, create analysis and miscellaneous requests, and any other activities related to the routine works). -Assure cleaning daily check for all balances in all production areas and assure the due date of calibration. -Reviewing of all production logbooks and assure that all activities recorded and compliance with GMP and GDP. -Receiving of all rejections from all stages with the rejection form and ensure that all rejections are kept in IPQA rejection room. -Receiving of all Packaging materials from WH and delivering to Production. -Create NCR & Stop the production process in case of any deviation.

Quality Assurance SpecialistFull Time

• Job Details:Follow-up & witness production & packaging activities to ensure compliance & perform necessary checks to ensure product quality. Ensure product proper labeling regarding identity & status to maintain product identity. Fully attend raw material handling steps whether in dispensing or during preparation to ensure material identity, batches & weight. Fully attend inspection/packaging start-ups to verify components used, ensure correct batch variables, checks inspection & verification instrumentation / equipment to assure its performance and participate in reconciliation that ensure complete traceability. Collect finished, retained, MOH & any additional samples to be delivered to concerned persons for storage and / or analysis. Witness process validation & equipment qualification & calibration studies to ensure adherence to PBI internal SOPs & on time performance according to plan. Participate in expired & rejected products disposal committees to ensure product reconciliation & complete destruction. Follow-up implementation of target market special requirements during processing & prior to product dispatch including packaging. Verify area cleanliness & clearance to assure compliance with GMP standards. Plan, execute, report & evaluate for internal audit activities for completeness, participate in assessment of CAPAs & coordinate CAPAs timely implementation with key stake holders. Implement recall testing periodically & participate in actual recalls as assigned. Issue NCR reports, deviations, NCR(s) risk assessment & review CAPAs to ensure CAPA effectiveness. Participate in relevant SOPs & BPR revision. Review all BPR records to ensure that data are correct, complete & within company acceptance criteria and accordingly, release or hold intermediates for further processing.