Nagham Samada'A Email & Phone Number

Sahab, Amman, Jordan

- Coordinate and follow up on CAPA, OOS, deviations, nonconformance and investigations.- Log received deviations under the supervision of QA Supervisor.- Coordinate with Maintenance regarding matters of preventive and corrective maintenance.- Assist with the preparation of failure investigations by collecting data and checking retained samples.- Assist with revising and developing SOPs.- Maintain documentation for materials to be destroyed and give consent to initiate the process.- Review and archive documents in compliance with good documentation practices.- Train new staff on any changes in the system.- Prepare summaries related to all QA activities (failure investigations, self-inspection, reprocessing evaluation and change control requests)- Coordinating with the Regulatory Affairs Department to follow up the registration matters for the validity duration of the product (Shelf Life) related issues for each country.- Coordinating with Quality Control department and the Microbiology Department to coordinate the analysis functions and the product batches' size and number and to find out the results of the analytical tests.- Handling the deviation management system.- Handling critical work maintenance system.- Handling the supplier complaint system- Checking the BMR before the final release

Sahab, Amman, Jordan

• 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.

Sahab, Amman, Jordan

• 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.

Sahab, Amman, Jordan

• 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.

Sahab, Amman, Jordan

• 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.

Sahab, Amman, Jordan

• Quality Assurance (QA).• Quality Control (QC).• Water treatment unit (RO).• Validation department.