مجموع سنوات الخبرة: 7 سنوات, 4 أشهر
يوليو 2010
إلى أغسطس 2012
Senior Quality Assurance Officer
في tabuk pharmaceuticals mfg. co.
البلد :
السودان - الخرطوم
promoting quality achievement and performance improvement throughout the organization;
setting QA compliance objectives and ensuring that targets are achieved;
assessing the product specifications of the company and its suppliers, and comparing with customer requirements;
working with purchasing staff to establish quality requirements from external suppliers;
ensuring compliance with national and international standards and legislation by being aware of regulatory requirements and ensure compliance in line with company's long term strategies;
considering the application of environmental and health and safety standards;
setting up and maintaining controls and documentation procedures;
identifying relevant quality-related training needs;
Evaluation of Q.A staff performance data and charts against defined parameters;
ensuring tests and procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessary;
liaising with customers' auditors and ensuring the execution of corrective action and compliance with customers' specifications;
To ensure and certified that each production batch has been produced and controlled in accordance with the requirements of the GMP and any other regulations relevant to the production, control and release of pharmaceutical products;
Manage all administrative issues related to Q.A department.
setting QA compliance objectives and ensuring that targets are achieved;
assessing the product specifications of the company and its suppliers, and comparing with customer requirements;
working with purchasing staff to establish quality requirements from external suppliers;
ensuring compliance with national and international standards and legislation by being aware of regulatory requirements and ensure compliance in line with company's long term strategies;
considering the application of environmental and health and safety standards;
setting up and maintaining controls and documentation procedures;
identifying relevant quality-related training needs;
Evaluation of Q.A staff performance data and charts against defined parameters;
ensuring tests and procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessary;
liaising with customers' auditors and ensuring the execution of corrective action and compliance with customers' specifications;
To ensure and certified that each production batch has been produced and controlled in accordance with the requirements of the GMP and any other regulations relevant to the production, control and release of pharmaceutical products;
Manage all administrative issues related to Q.A department.
يوليو 2006
إلى يونيو 2010
Quailty Assurance Officer
في Sigma_tau
البلد :
السودان - الخرطوم
Full compliance to Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP)
Equipment, process and utilities validation
Writing Standard Operating Procedures based and EU guidelines.
Tracing documents and reviewing it
Continuous training and upgrading the knowledge of quality observance.
Realse of batches
Internal Audit of the plant.
Training coordinator.
Equipment, process and utilities validation
Writing Standard Operating Procedures based and EU guidelines.
Tracing documents and reviewing it
Continuous training and upgrading the knowledge of quality observance.
Realse of batches
Internal Audit of the plant.
Training coordinator.
مايو 2005
إلى يوليو 2006
Production Supervisor
في Sigma_Tau
البلد :
السودان - الخرطوم
To ensure that products are manufactured and stored according to the appropriate documentation in order to obtain the required quality.
To ensure that the necessary training of production personnel is carried out and adapted according to need.
To approve the instructions relating to production operations and to ensure their strict implementation.
To ensure that the production records are evaluated and signed by a designated person before they are transmitted to the Quality Control department.
To check the maintenance of the department, premises, and equipment.
To ensure that the appropriate validation and calibration of control equipment is performed and recorded.
To ensure that the necessary training of production personnel is carried out and adapted according to need.
To approve the instructions relating to production operations and to ensure their strict implementation.
To ensure that the production records are evaluated and signed by a designated person before they are transmitted to the Quality Control department.
To check the maintenance of the department, premises, and equipment.
To ensure that the appropriate validation and calibration of control equipment is performed and recorded.
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