Validation Specialist At Grifols Egypt
JOB OBJECTIVE:
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: GEPD general management members, manufacturing, quality & service divisions.
External: In absence of Validation Manager, equipment suppliers, Health Authorities, government authorities and auditors.
KEY RESPONSIBILITIES:
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.
LANGUAGES
Written and spoken English and Arabic.
Location: EMEA : Egypt : Egypt:EGTOLIP – Tolip El Narges-New Cairo