Senior Quality Assurance Officer
tabuk pharmaceuticals mfg. co.
Total des années d'expérience :7 years, 4 Mois
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.
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.
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.
My MSc project was Proposal for Model for Excellence Quality Award Based on ISO Standards (ISO 9001:2000, ISO 9004:2000 , ISO 14001 Environment Management System , OHSAS occupational health and safety assessment specification and SA8000 social accountability) the developed model applied in Fargall group and in Alex carbon black Company .