Diaa Mohammed

Quality Assurance - IPC

• Job Details:Checking the production area: making sure that all GMP rules are followed according to batch record & SOPs of relevant area. Withdrawal of needed samples during various steps according to sampling plan. Perform second check for all critical steps in processing areas, packaging areas. Making sure that all parameters are conformed to all requirements for each step of the manufacturing process and ensure the presence of all calibrated sticker on all sensors and gauges as required. Assist in investigation of any process deviation. Check the correct reading/recording of (RH%, temp, and diff, pressure in all areas as per authorized SOP. Validating activities in the plant: assisting in all qualification and validation activities in the plant. Preparing and filling medium fluid TSB for aseptic products. Reviewing manufacturing orders: review manufacturing orders bulk, filling and packaging according to master formula, packaging formula and certificate of analysis. Annual product quality review (APQR): doing annual product quality review (APQR), data analysis, report data in file and collecting data. Dispensing and warehouse area: checking all steps in dispensing area and checking the warehouse area.