• Improving the Quality Management Systems in a company that manufactures drug products in different dossage forms such as parenteral solutions, sterile ampoules, vials, lyophilized powders, BFS and PFS, by considering the current authority and customer expectations.• Improving the relationship with contractors and suppliers.• Taking active part in the recruitment and mentoring of QA Specialists/Supervisors.• Organizing the release activities such as reviewing batch manufacturing records and analytical results and ensuring that all the products meet the approved specifications prior to authorizing their release.• Ensuring that all the planned internal and external audits are carried out in a timely manner.• Handling the encountered technical issues, ensuring the proper investigation of the root cause and organizing the initiation of the necessary CAPA’s.• Maintaining the company’s SOP system including Quality System Manuals.• Reviewing and approving all trend reports related to the encountered deviations, out of specifications/ out of trends/ out of expectations, customer complaints and change controls.• Concluding and maintaining Quality Agreements with contract manufacturers by ensuring the adherence to GMP requirements.• Supervising and coordinating the investigation of Customer Complaints and Non-conformities.• Participating in the development and maintenance of corporate/site policies and procedures.

-Establishment of all Quality System in new biotechnology manufacturing site in view of national and international GMP regulations.-Management of Quality team which are responsible of ensuring GMP compliance in manufacturing, quality control, engineering, validation/ qualification, warehousing, distribution operations according to national and international GMP guidelines.-Management of GMP inspections for raw material suppliers, service providers and contract manufacturers.-Coordination of internal/ external inspections and Health Authority inspections.-Management of quality systems including SOP, documentation, personnel training & qualification, complaints, deviations, change control, OOS/OOE, product quality review, recalls, CAPAs.-Supporting technology transfer activities, product registration process,-Building close communication with Ministry of Health officials.

Batch Documentation and Release Supervisor:To ensure that 9000 batch products, production and analysis records are checked and released through SAP system with a team of 11 people,To ensure in-process controls of secondary packaging operations carried out in the contracted agent pharmaceutical warehouse and to evaluate market returns,Ensuring the coordination required for release and documentation with the subcontractor and other internal departments.

Release Coordinator:Final control of local, export and import products' mass production records according to GMP eligibility requirements and release via SAP system,Transmission of analysis certificate and batch records of the products to related countries, system management of electronic batch record archive,SOP system management, creation of up-to-date SOP lists, ensuring completion of trainings,

GMP Coordinator:To ensure GMP-GDP compliance of Secondary Packaging, Warehouse and Shipment areas,To check and releasing Secondary Packaging Department Reports,To open, monitor and evaluate deviations,Evaluation of customer complaints,

Novartis Pharmaceuticals, Imported Pharmaceuticals Price Printing Planning and In-process Responsible:Secondary packaging and price printing line planning, product, personnel and material follow up of a working group of 80 people according to demands from Sales Department.

Warehouse Responsible

Manufacturing In-Proses Control Responsible