أخصائي تدقيق الجودة

Job description

About the job Quality Audits Specialist

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.
Academic experience required
- Bachelor's degree in Health-related Sciences.
- Proven experience in GMP auditing within a Pharmaceutical Company is preferred.
- Knowledge of eGMP requirements.
- Auditor certification preferred.
Professional Experience Required
Minimum of three years of related experience in Quality Assurance and two year of Quality Audits experience in Pharmaceutical Industry.
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.