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Validation Specialist ( New Capital)
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.
- 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).
-
Typically requires 1 to 3 years of validation experience in Pharmaceutical industry under GMP.
- 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.
-
2 of 3
-
Written and spoken English and Arabic.
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