Nagham Samada'a
Quality Assurance Engineer at MS PHARMA- Claim this Profile
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Bio
Experience
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MS PHARMA
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Jordan
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Assurance Engineer
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Oct 2022 - Present
• Handling of change control system (CCR) and document change control system, responsible for evaluating andperform assessment for all type of CCR's and follow up site change controls progress.• Ensure proper assessment and review of all SOP’s prepared by QA and related departments through Qmexsystem.• Responsible for document management systems through proper implementation of document life cycle (e.g., SOPs, Forms, Instructions, Logbooks, etc) from initiation to destruction.• Issuance of batch records i.e related to manufacturing process and packaging.• Follow up Deviations and out of specification system.• Follow up Corrective and Preventive Action (CAPA) system.• Follow up investigation reports using the root cause analysis.• Review the Building Management System (BMS) reports. • Archiving all documents including batch records. Show less
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Validation Engineer
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Jul 2022 - Oct 2022
• Validation, Qualification and verification of equipment in production and other departments.• Follow up engineering projects from Users Requirement Specification (URS), Design Qualification (DQ), Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Site Acceptance Test (SAT) and Factory Acceptance Test (FAT). • Handling process validation of new and existing products.• Preparing all documentation related for validation activities such as VMP, protocols, reports etc.• Handling thermal mapping for refrigerators, freezers, incubators, ovens, stability chambers and warehouses.• HVAC system.• Compressed Air System. Show less
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Quality Documentation Officer
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Dec 2021 - Jul 2022
• Handling of change control system (CCR) and document change control system, responsible for evaluating and perform assessment for all type of CCR's and follow up site change controls progress. • Ensure proper assessment and review of all SOP’s prepared by QA and related departments through Qmex system. • Responsible for document management systems through proper implementation of document life cycle (e.g., SOPs, Forms, Instructions, Logbooks, etc) from initiation to destruction.• Issuance of batch records i.e related to manufacturing process and packaging.•Coordinate all training activities related to QA documentation staff such training file, training matrix, training program, etc.. •Maintain department performance through establishment of appropriate KPI's. • Leading of all activities related to 6s. Managing all activities related to quality central archive area. Show less
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Atlas Medical GmbH
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Germany
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Hospitals and Health Care
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1 - 100 Employee
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Quality Assurance Engineer
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Mar 2021 - Dec 2021
• Initiate coordinate and monitor product quality improvement, final product and process quality level. • Ensure that visual and physical measurement and result production process are checked. • Checking batch manufacture and testing in accordance with defined release procedures. • Handling deviations, complaints and CAPA analysis. • Initiate and review SOP’s prepared by QA and related department. • Responsible for document management systems (e.g., SOPs, Forms, Instructions, Logbooks, etc). • Follow up change control system (CCR) and document change control systems. Show less
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MS PHARMA
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Jordan
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Pharmaceutical Manufacturing
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700 & Above Employee
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chemical engineer trainee
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Jul 2020 - Dec 2020
• Quality Assurance (QA). • Quality Control (QC). • Water treatment unit (RO). • Validation department. • Quality Assurance (QA). • Quality Control (QC). • Water treatment unit (RO). • Validation department.
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Education
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University of Jordan
Bachelor's degree, Chemical Engineering