Senior Validation Specialist

Job Objective

The Validation Specialist is a technical professional, responsible for the completion of all phases of assigned qualification and validation projects ensuring the correct manufacturing process to be implemented and the full compliance to regulatory standards and Grifols Egypt for Plasma Derivatives (GEPD) requirements.

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.
• Edition and commitment to the validation master plans.
• Technical assessment of change controls, deviations (taking part in the investigations), and CAPAs related to the processes developed in GEPD.
• Knowledge of the GMP practices and application to the activities developed.

Academic experience required

• Bachelor's degree on Engineering or Health-related Sciences.
• Knowledge of current Good Manufacturing Practices (cGMP)

Professional Experience Required

Typically requires 5 to 7 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.

Languages

Written and spoken English and Arabic.