Product Release Specialist at Grifols Egypt for Plasma Derivatives | Torre

Product Release Specialist

You will ensure vital product release, advancing healthcare access and regulatory excellence.
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Full-time

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New Cairo City, Cairo Governorate, Egypt
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Posted 4 months ago

Requirements and responsibilities


About the jobProduct Release Specialist is responsible for the of Finished Product Importation and Exportation submissions to Health Regulatory Agencies to ensure the final release, as well of support for pharmacovigilance tasks related of the Finished Product in the market.Key responsibilityRevision and submission of Finished Product documentation required for Finished Product Importation / Exportation, ensuring final release of the product.Coordinate delivery of samples to National Health Authorities (EDA) required for Finished Product release.Ensuring compliance with current Finished Product Importation / Exportation and release regulations and guidelines.Maintain efficient Regulatory Affairs documentation archive.To assist Regulatory Affairs Manager in any assigned duties.Academic experience requiredBachelors Degree in Health-related Sciences, preferably pharmaceutical area.Knowledge of cGMP requirements; Good storage and Distribution practice.Professional experience requiredMinimum of 2 years of related Reg Affairs Product Importation / Exportation experience in a pharmaceutical, GMP environment is required.Comprehensive knowledge and understanding of cGMPs, EMA regulations.Computing skillsMS Office knowledge.Specific experience with SAP is preferred.Personal skillsOrganized 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.Strong integrity and commitment to quality and compliance.LanguagesExcellent verbal and written communication skills in the English and Arabic language
Optionally, you can add more information later (benefits, pre-screening questions, etc.)
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