✨ AI Summary
The Quality Documentation Specialist is responsible for controlling, monitoring, and recording all activities impacting product quality, donor suitability, and safety. This role ensures the accuracy, integrity, availability, and legibility of documents through implementing suitable controls. Key responsibilities include preparing and reviewing SOPs following Egyptian regulations and cGMP guidelines, compiling documentation lifecycle information, and defining a system for regular document review and updates. The specialist must ensure documents are carefully designed, prepared, reviewed, and distributed, with approved and dated instructions, unambiguous content, and clear identification. A Bachelor's degree in Health-related Sciences, knowledge of Quality Management and Good Documentation Practices, and computer proficiency are required. Experience in GMP Documentation Systems within a pharmaceutical company is preferred, along with strong organizational and communication skills.
Requirements
Bachelor's Degree in Health-related Sciences. Knowledge of Quality Management and Good Documentation Practices. Proficiency in computers. Organized and able to manage time effectively. Ability to work within a highly regulated environment and enforce SOPs. Written and spoken English and Arabic.
Description
JOB OBJECTIVEResponsible of ensuring to control, monitor and record all activities which directly or indirectly impact on all aspects of the product quality, donor suitability and donor safety, as well as plasma testing and plasma warehouse.Responsible of implementing suitable controls to ensure the accuracy, integrity, availability and legibility of documents.KEY RESPONSIBILITIESPrepare and review SOPs related to Documentation Lifecycle Systems following the guidelines established according to Egyptian regulations and the guidelines established according to cGMP requirements and Good Documentation Practices.Compile all the information related to Documentation Lifecycle referred to Key Process indicators established for the Quality system.To define a system of control of documentation that ensures that documents within the Quality Management System should be regularly reviewed and kept up to date.To ensure that documentation should be designed, prepared, reviewed and distributed with care. The reproduction of working documents from master documents should not allow any error to be introduced through the reproduction process.To ensure that Documents containing instructions should be approved, signed and dated by appropriate and authorized persons.Documents should have unambiguous contents and be uniquely identifiable. The effective date should be defined.KEY RESPONSIBILITIES- Bachelor s Degree in Health-related Sciences.- Knowledge of Quality Management, as Good Documentation Practices.- Knowledge of cGMP requirements preferred.- Typically requires a minimum of 2 years of related experience in GMP Documentation Systems within a Pharmaceutical Company preferred.- Proficiency in Computers.- Organized and able to manage time effectively.- Ability to work within a highly regulated, labor-intensive environment.- Ability to understand, explain, follow, and enforce SOPs and protocols- Ability to plan, communicate and execute activities for the improvement of overall operations.- Written and spoken English and Arabic.