Quality Audits Specialist

Grifols Egypt for Plasma Derivatives

Key responsibility

• Preparation of GEPD Internal and External Audit program and audit plan on annual basis.
• Execute assigned risk-based GMP audits for GEPD activities, following the audit plan.
• Perform internal audits to verify compliance with Egyptian Regulation, cGMP requirements, and Health Authority license conditions to ensure product quality and safety.
• Conduct supplier qualification audits and evaluate performance against established KPIs.
• Prepare audit reports and escalate significant issues to the Audits Manager.
• Maintain personal auditor competence through ongoing GMP training, and adherence to Quality standards.
• Apply regulatory updates to daily audit activities to ensure compliance with current GEPD, EMA, and Egyptian cGMP standards and other regulations (as required).
• Support the implementation and maintenance of audit systems, checklists, and quality processes.
• Assist in preparing for and participating in regulatory inspections and notified body audits.

Computing Skills

Proficiency with computers using Microsoft office.

Personal Skills

• Organized and able to manage time effectively.
• Ability to work within a highly regulated, labor-intensive environment.
• Analytical and enquiring mind with the ability to interpret data and facts.
• Excellent oral and written communication skills to produce clear and concise factual findings and the ability to present effectively to groups.
• Effective organizational and planning skills with the ability to meet deadlines required.

Languages

Fluent in English and Arabic, with advanced proficiency in English communication skills.