Hossam Moustafa Email & Phone Number

Alexandria, Egypt

Alexandria Governorate, Egypt

Responsible for performing sampling, routine and specialized testing of raw materials in compliance with Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). Responsible for subcontract sample preparation, shipment, and receipt of associated data. Performs sampling of raw materials per approved procedures and specifications. Performs routine and specialized raw material testing according to Standard Operating Procedures and Pharmacopeia methods, in compliance with cGMP. Communicates with subcontract labs to obtain information regarding capabilities, test timelines, and costs for testing unable to be performed in-house. Prepares sample shipments and submission paperwork for contract laboratory testing. Performs project related tasks as assigned with general instructions. Initiates and assists with OOS/deviation investigations. Writes and revises Standard Operating Procedures (SOPs). Performs general lab support activities such as housekeeping, equipment maintenance, inventory/ordering of supplies. Maintains compliance with all required training. Trains other analysts on basic procedures.Runs analytical method transfer and qualification/validation experiments per approved protocols and with general instruction. Performs other duties as assigned.Skills Technical Skills Prior experience with raw material testing such as wet ID, spectroscopy, titration, pH, osmolality, and/or conductivity a plus Knowledge Demonstrates a solid understanding of cGMP principles. Able to identify breach of cGMP principlesAcquires and documents training on all laboratory general tasks and is capable of performing assigned test methods and using associated instrumentation. Understanding of basic laboratory equipment and aseptic technique a plus.Highlights UV,IR,LC-MS,GC,HPLC Column chromatography-Karl fischer-Titrations. Method Development

Egypt

- have permission to enter the sterile area form the company medicinal products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practice:Duties: - Responsible for monitoring and maintaining quality and compliance targets. - Monitoring and auditing of products to ensure high standards of quality. - Ensuring products comply with legislation and quality assurance codes. - Ensuring that all QA Tests are carried out on time and in full. - Delivering presentations to an audience of Manager Level within the business. - Provide weekly and monthly reports to senior managers on performance. - Identify training needs and recommendations to improve customer experience. - Keeping quality documentation up to date. - Making sure that all QA records, data & information are available to managers. - Arranging the repair of any QA / related equipment that is malfunctioning. - Ensuring non-conforming products are identified and placed on restriction. - Responsible for the review and update of the programme quality plans. - Awareness of regulatory requirement and customer service expectations. - Ensuring activities in the quality plan are carried out. - Coordinating the investigation of customer complaints.Project participate Annual participation in internal inspection. Standard operation procedure of the quality assurance team in the factory. Checklist of the quality assurance team in the factory. Follow-up with the inspector of the Ministry of Health in drug execution. Participate Annual Product Review(APR) in data collection and Data entry and Data analysis. Participate in the Validation and Calibration of all tests of the cabin filling sterilized Product and for Area Class (B,C) LIKE (DOP test,Air Velocity)

Egypt-Alexandra

TestUrineCalciumFragility TestHaemoglobin analysisBlood group testTriglycerides testAntibiotic Susceptibility TestBleeding timeUrea-Creatinine-Creatinine Clearance Test-Water Depletion-Gout-Semen analysis