Grifols Egypt for Plasma Derivatives (GEPD)

Quality Systems Specialist

Grifols Egypt for Plasma Derivatives (GEPD)  •  Arab Republic of Egypt (Onsite)  •  8 days ago
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Job Description

JOB OBJECTIVE

Responsible of ensuring that Quality System in place is in compliance with Egyptian Regulation and in accordance to FDA and EMA Regulation, staying abreast of current and new regulations in order to analyze their impact on Quality system established.

KEY RESPONSIBILITIES

  • Prepare and review SOPs related to Quality Systems following the guidelines established according to Egyptian regulations and the guidelines established according to cGMP requirements.
  • Establish a defined Deviation procedure and CAPA system, involving appropriate stakeholders for investigation and closure.
  • Compile all the information related to the different processes referred to Key Process indicators established for the Quality system.

ACADEMIC EXPERIENCE REQUIRED

  • Bachelor s Degree in Health-related Sciences
  • Knowledge of Quality Management.
  • Knowledge of cGMP requirements preferred

PROFESSIONAL EXPERIENCE REQUIRED

Typically requires a minimum of 2 years of related experience in GMP Quality Systems within a Pharmaceutical Company preferred.

COMPUTING SKILLS

Proficiency in Computers

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.

LANGUAGES

Written and spoken English and Arabic

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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