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.
Grifols Egypt for plasma derivatives is a joint-venture (JV) company between the Egyptian Government, through the National Service Projects Organization (NSPO) and Grifols, the global leader in plasma medicines with more than 110 years of contribution to improving the health and well-being of people.
This joint venture is the first of its kind in the plasma industry and the first-ever Egyptian source member of the Plasma Protein Therapeutics Association (PPTA). GEPD is a groundbreaking global public-private alliance that will benefit the entire region.
GEPD is committed to developing the plasma medicines market and achieving self-sufficiency in these critical therapies, which is crucial for the Egyptian healthcare system.
We are combining the expertise of both shareholders to build and operate 20 plasma donation centers throughout Egypt, along with manufacturing facilities including fractionation, purification, and fill-and-finish plants with a processing capacity of up to 1 million liters of plasma annually that can double in the future.
The new manufacturing facility will include a plasma warehouse and a testing laboratory. It will occupy 105,000 square meters strategically located in the administrative capital’s medical city, adjoining various healthcare institutions.
