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Product Release Specialist at GRIFOLS, S.A.
Cairo, Cairo, Egypt -
Full Time

Start Date

Immediate

Expiry Date

26 Sep, 26

Salary

0.0

Posted On

28 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Affairs, Product Importation, Product Exportation, Pharmacovigilance, cGMP, EMA Regulations, SAP, MS Office, Documentation Management, Compliance

Industry

Pharmaceutical Manufacturing

Description
Product 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 responsibility Revision 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 required Bachelors Degree in Health-related Sciences, preferably pharmaceutical area. Knowledge of cGMP requirements; Good storage and Distribution practice. Professional experience required Minimum 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 skills MS Office knowledge. Specific experience with SAP is preferred. Personal skills 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. Strong integrity and commitment to quality and compliance. Languages Excellent verbal and written communication skills in the English and Arabic language
Responsibilities
Responsible for managing finished product importation and exportation submissions to health regulatory agencies to ensure final product release. Provides support for pharmacovigilance tasks and maintains regulatory affairs documentation archives.