Key responsibility

- Prepare 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.