Responsible Pharmacist

Job Description

● Supervising the preparation of each batch history according to the established criteria and releasing the product's distribution after ensuring the documentation's completion.
● Submitting documents (CTD) to the Food and Drug Organization to obtain a new license.
● Timely action to renew the company's current product manufacturing license.
● Receiving periodic inspection reports from the experts of the General Administration of Drug Affairs and presenting them to the CEO and relevant units of the factory in order to carry out corrections and eliminate defects and follow up on the elimination of defects and report corrective measures to the General Administration of Drug Affairs.
● Receiving and communicating all the regulations of the Ministry of Health, Treatment, and Medical Education regarding the production of pharmaceutical products (including formulation, manufacturing, control, packaging, and storage) to the relevant units in the factory and monitoring their compliance.
● Supervising the development of product documentation based on the criteria contained in the CTD product manufacturing license in accordance with GMP.
● Monitoring the implementation of product production rules based on CTD and written procedures (SOP) of production Supervising the registration of manufacturing and packaging information for each product.
● Planning for continuous improvement and improvement of manufacturing and packaging methods based on quality control laboratory results.
● Conducting internal inspections and communicating the results to the relevant units to eliminate defects.
● Examining material samples of new resources, confirming them, and adding new resources to the product license.
● Evaluating and visiting sources that produce pharmaceutical raw materials and packaging requirements and preparing the necessary reports and sending them to the General Directorate of Drug Affairs Supervision Monitoring compliance with regulations and regulations of the Ministry of Medicine, Health and Medical Education regarding material orders.
● Monitoring the implementation of the rules for ordering raw materials and packaging materials and controlling the quality of practical and auxiliary raw materials and the ordered packaging according to the specifications accepted in CTD Obtaining the approval of the factory's quality control laboratory regarding raw materials and packaging requirements according to GMP standards and checking it and releasing the raw materials and packaging for use in drug production and packaging after ensuring the completeness of their specifications according to the established standards.
● Supervising the formulation of control procedures for raw materials, packaging, semi-finished products, and finished products based on the specifications listed in CTD and in compliance with GLP considerations.
● Monitoring the compliance and implementation of the standards and regulations contained in GMP in the warehouses and the weighing section in the fields of moving materials from warehouses to units and exiting the factory, adjusting and calibrating the equipment and devices of the weighing section and the general and special technical conditions of the warehouses and weighing section.
● Announcing the final approval (green label) for products made in production and analyzed in the quality control laboratory Final release of products in the TTAC system for sale to broadcasters.