Lecturer

• Sep 2017 - Present

Building#1 QA IPC Manager

• May 2013 - Present

Implementing quality systems in accordance with applicable company quality standards Elaborating a documentation system based on company quality procedures Implement and drive a risk management system Deploying global e-systems and having the role of local key user (e.g.: TrackWise, Mango) Handling of deviation, complaint, change control, CAPAs systems Manage in coordination with global functions critical issues like product alert, recall, withdrawals Manage quality aspects of storage, distribution and cold chain for the region including: qualification of storage, distribution and cold chain following current international GDP guidelines Reporting and handling shipment T° deviations Shipment T° assessment and release Assure inspection readiness of regional activities, coordinate and follow up Health Authorities inspections and related CAPAs Manage all quality related aspects of GxP vendors (e.g.: distributors, CMOs) including: Qualification, approval and establishment of technical agreements Elaboration and execution of audit program Review and follow up of related CAPAs until closure Handling of quality issues with the vendors (e.g.: quality deviation, complaint) perform batch disposition of products manufactured by CMOs in compliance with Marketing Authorization (if applicable) Review and approve major changes Define an internal audit program and ensure that audits are performed and related CAPAs followed and closed Assure that personnel involved in GMP/GDP tasks are trained and qualified Implement and execute Quality Management Reviews and Quality Risk Management systems Show less

Quality Assurance Manager

• Apr 2012 - Present

• Identify, plan and manage external audit resources as needed to implement the annual Pharma QA audit plan• Partner with QA and relevant GMP business functions to ensure that effective corrective and preventive actions (CAPAs) are identified and implemented• Provide support for the management and follow up to HA inspections of Pharma GMP operations • Extensive QA/industry/health authority experience of increasing responsibility with at least 5 years in conducting GMP audits• Extensive management experience; strong management skills to lead, coach and mentor associates with diverse background • negotiation and interpersonal skills and ability to communicate effectively with all levels of the organization• Check Batch records review ,release and Annual Product Review.• Monitoring of QA cycle Show less

Head of Quality Assurance Team of Enteric Bacterial Vaccines & Sera Production Line

• Oct 2011 - Mar 2012

checking the environmental monitoring program for air, water and validation of steam sterilizers.daily checking the sampling plan for water and air points in building.taking corrective and deviation action.checking temperatures for incubators, refrigerators, cold room .checking cleaning and disinfection of sterile area

Environmental monitoring specialist and disinfectant evaluator

• Nov 2005 - Oct 2011

•Microbial monitoring of pharmaceutical water using membrane filtration & pour plate techniques. •Microbial monitoring of air (active and passive), surfaces and personnel. •Microbiological control on sterile and non sterile pharmaceutical products. •Bacterial isolation, staining and identification through biochemical testing. •PCR, Restriction analysis for detection of actions in environmental monitoring program. •Evaluation of bactericidal, fungicidal, mycobactericidal, sporicidal and virucidal efficacy of biocides. •MIC determination, antibiotic sensitivity and antibiotic assays. •Validation of steam sterilizers using biological indicators Show less

Environmental monitoring specialist

• Apr 2004 - Nov 2005

Establish an environmental monitoring program for air ,water, surfaces and personnel in pharmaceutical facility. biochemical identification of environmental isolates. detection of pathogenic microorganisms for syrups, ointment, capsules, tablets. perform sterility test on injectables. MIC for antibiotics. Establish an environmental monitoring program for air ,water, surfaces and personnel in pharmaceutical facility. biochemical identification of environmental isolates. detection of pathogenic microorganisms for syrups, ointment, capsules, tablets. perform sterility test on injectables. MIC for antibiotics.