Validation Specialist

Job Objective

• One sentence summary of the main objective of the job, the most important activities and
• the means and guidelines to obtain the objectives.
• The Validation Specialist is a technical professional, responsible for the completion of all
• phases of assigned qualification and validation projects ensuring full compliance to
• regulatory standards and Grifols Egypt for Plasma Derivatives (GEPD) requirements.
  
  
  

Environment

Internal and external interactions i.e.: with other departments/divisions, international scope, providers, customers)

Internal: GEPD general management members, manufacturing, quality and service divisions.

External : In absence of Validation Manager, equipment suppliers, Health Authorities,

government authorities and auditors.

Key responsibility

• Primarily responsible for the design, authorship, and execution of qualification and validation protocols.
• Generation, calculation, interpretation and review of the raw data obtained during the
• qualification and validation studies.
• Edition and follow up of qualification and validation reports.
• Technical assessment of change controls, deviations (taking part in the investigations),
• and CAPAs related to the processes developed in GEPD.
  
  
  

Academic Experience Required

• Bachelor's degree on Engineering or Health-related Sciences.
• Knowledge of current Good Manufacturing Practices (cGMPs).
• Professional Experience Required
• Typically requires 1 to 3 years of validation experience in Pharmaceutical industry under GMP.
  
  
  

Computing Skills

Knowledge of Microsoft Office applications.

Personal Skills

• Excellent oral and written communication skills.
• Strong critical thinking, analytical skills and problem-solving skills.
• Organized and able to manage time effectively.
• Ability to work with others in a team environment.
• Continuous improvement according to increasing job knowledge.