Product Release Specialist
Grifols Egypt for Plasma Derivatives
Employer Active
Posted on 31 Mar
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Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
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.
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.
Desired Candidate Profile
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.
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- R&D
- Research & Development
Keywords
- Product Release Specialist
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Grifols Egypt for Plasma Derivatives
https://www.careers-page.com/grifols-egypt-for-plasma-derivatives/job/4RRR7YW7