Grifols Egypt for Plasma Derivatives (GEPD)

Manufacturing Validation and Calibration documentation specialist (New Capital)

Grifols Egypt for Plasma Derivatives (GEPD)  •  New Cairo, EG (Onsite)  •  4 days ago
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Job Description

Job Objective

A Manufacturing Validation and Calibration Documentation Specialist is responsible for supporting in creating, maintaining, and controlling technical documentation related to equipment validation, calibration, and compliance activities within new capital manufacturing Site and calibration documentation of Donor centers.

Environment

  • Internal: Manufacturing, quality, Engineering, & service divisions
  • External: suppliers, Health authorities, Government authorities, and Auditors.

Key responsibility

  • Handle and Maintain validation documentation, including:
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Validation protocols and reports
  • Handle and Maintain calibration records for manufacturing and laboratory equipment
  • Ensure documentation complies with:
  • GMP (Good Manufacturing Practices)
  • ISO standards
  • FDA or other regulatory requirements
  • Coordinate some activities with internal stakeholders such as engineering, quality assurance, manufacturing, and maintenance teams. As well as external Vendors and service providers.
  • Review technical changes and update controlled documents
  • Support audits and inspections by providing accurate records
  • Track calibration schedules and validation status
  • Track pending documents on DCM.
  • Assist with department related deviation investigations and corrective actions (CAPA)
  • Assist with department related change controls and their actions.

Academic experience required

  • Bachelor's degree in technical or scientific field.
  • Knowledge of current Good Manufacturing Practices (cGMP).

Professional Experience Required

  • 0-2 years of experience in pharmaceutical field.

Computing Skills

  • Basic knowledge of Microsoft office and software systems (SAP)
  • Familiarity in using maintenance management software systems (SAP PM or similar).
  • Familiarity in using BMS Software program

Personal Skills

  • Good Communication skills
  • Strong technical writing and document control abilities.
  • Attention to detail and organizational skills.
  • Good organizational and time management skills.
  • Ability to work independently and as part of a team.
  • Familiarity with calibration and validation systems.
  • Familiarity with GMP and quality requirements.
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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