Grifols Egypt for Plasma Derivatives (GEPD)

Product Release Specialist

Grifols Egypt for Plasma Derivatives (GEPD)  •  Arab Republic of Egypt (Onsite)  •  19 days ago
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Job 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

Grifols Egypt for Plasma Derivatives (GEPD)

About Grifols Egypt for Plasma Derivatives (GEPD)

Grifols Egypt for plasma derivatives is a joint-venture (JV) company between the Egyptian Government, through the National Service Projects Organization (NSPO) and Grifols, the global leader in plasma medicines with more than 110 years of contribution to improving the health and well-being of people.

This joint venture is the first of its kind in the plasma industry and the first-ever Egyptian source member of the Plasma Protein Therapeutics Association (PPTA). GEPD is a groundbreaking global public-private alliance that will benefit the entire region.

GEPD is committed to developing the plasma medicines market and achieving self-sufficiency in these critical therapies, which is crucial for the Egyptian healthcare system.

We are combining the expertise of both shareholders to build and operate 20 plasma donation centers throughout Egypt, along with manufacturing facilities including fractionation, purification, and fill-and-finish plants with a processing capacity of up to 1 million liters of plasma annually that can double in the future.

The new manufacturing facility will include a plasma warehouse and a testing laboratory. It will occupy 105,000 square meters strategically located in the administrative capital’s medical city, adjoining various healthcare institutions.

Industry
Chemicals & Materials
Company Size
501-1,000 employees
Headquarters
Cairo, EG
Year Founded
Unknown
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