Quality System Manager (EGYPT)
Job Description
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.<p><br></p><strong>JOB OBJECTIVE</strong><p><br></p><ul><li> To define Control of Documentation system in order to ensure 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</li><li> To implement suitable controls to ensure the accuracy, integrity, availability and legibility of documents. Instruction documents should be free from errors and available in writing.</li></ul><p><br></p><strong><u>Key Responsibilities</u></strong><p><br></p><ul><li> Knowledge of Regulation framework to ensure that all the processes are in compliance with all applicable Egyptian Regulation, as well as company-designated regulations.</li><li> To define structure of documentation of the Quality system.</li><li> 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.</li><li> 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.</li><li> 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.</li><li> To edit SOP’s in accordance to the processes established to ensure to control, monitor and record all activities which directly or indirectly impact on all aspects of the product quality, donor suitability and donor safety.</li><li> To establish KPI related to Control of documentation in order to minimize potential documentation outdated.</li><li> To work with Plasma Quality Assurance Manager for keeping updated all the documentation at center level, plasma testing laboratory level and plasma warehouse level.</li></ul><p><br></p><strong><u>Academic Experience Required</u></strong><p><br></p><ul><li> Bachelor’s degree in health-related Sciences.</li><li> Post-graduated in Quality Management preferably</li><li> Knowledge in Good Manufacturing Practices as well as Good Documentation Practices.</li></ul><p><br></p><strong><u>Professional Experience Required</u></strong><p><br></p>At least 2 years of experience in a similar position, preferably in a pharmaceutical and multinational context, in environments of Good Manufacturing Practices.<p><br></p><strong><u>Computing Skills</u></strong><p><br></p>MS Office knowledge<p><br></p><strong><u>Personal Skills</u></strong><p><br></p><ul><li> Organized and able to manage time effectively.</li><li> Ability to work within a highly regulated, labor intensive environment.</li><li> Analytical and enquiring mind with the ability to interpret data and facts.</li><li> Excellent oral and written communication skills to produce clear and concise factual findings and ability to present effectively to groups.</li><li> Effective organizational and planning skills with ability to meeting deadlines required.</li></ul><p><br></p><strong>LANGUAGES</strong><p><br></p>Written and spoken English and Arabic.<p><br></p><strong>Location: EMEA : Egypt : Egypt : EGTOLIP – Tolip El Narges-New Cairo </strong><p><br></p>Learn more about Grifols<p><br></p>
