GMP consultancy to support EDA Vacancy-Job Ref: JKEGWHO/1309/202044

GMP consultancy to support EDA Vacancy-Job Ref: JKEGWHO/1309/202044

Cairo (Egypt)

JOB DESCRIPTION
QUALIFICATIONS

1. Purpose of consultancy
The main objective of this consultancy is to enhance the GMP inspection inside the EDA to ensure the compliance of EDA regulatory inspection functions with WHO standards as per the Global benchmarking tool requirements.
2. Background

As Egypt is one of the main producers of medical products including vaccines in Eastern Mediterranean Region (EMR). WHO has been providing support to the national regulatory authorities of Egypt since 1998, and more intensively since 2006.

Egypt was assessed in 2010 and recognized by WHO as functional regulatory authority for regulation of vaccines. The medical products regulatory system in Egypt has been restructured in 2019 with the establishment of the Egyptian Drug Authority (EDA).

In light of the Egypt vision 2030 and to enhance and develop the pharmaceutical sector in Egypt, the creation of a robust national regulatory authority as an autonomous entity has been a crucial pillar in the process and in accordance with the Law (Law No. 151, 2019), the Egyptian Drug Authority is the only entity in charge of drug control, registration, pharmacovigilance, trade and supervision, it is also responsible for issuing operational licenses to pharmaceutical industrial establishments.

The creation of EDA was aligned with recommendations provided by WHO during the assessment of the regulatory system in Egypt and consequent follow ups and discussions.

EDA is the sole regulatory body to oversee the quality, safety, and efficacy of the medical products in Egypt.

EDA was benchmarked by WHO in March 2022. WHO announced that Egypt has reached maturity level 3 for vaccines regulation (locally produced and imported).

Medicine regulatory system, on the other side, is being prepared for WHO benchmarking.

Strengthening vaccine and medicine good manufacturing practices (GMP) regulatory inspection (RI) function was identified as one of the areas for further improvement during the last formal benchmarking of the vaccine regulatory system as well as the self-benchmarking of medicine regulatory system and accordingly an advanced GMP workshop has been held in Egypt for 30 inspectors from EDA in February 2023.

EDA’s observed GMP audit has taken place by WHO team in July 2023 and many areas of improvements have been recognized related to the preparation, procedure, reporting of findings including the skills and competencies of the inspectors during the GMP inspection.

3. Work to be performed

Output 1: Conduct situational analysis for the status of GMP inspection in the National Regulatory Authority

· Deliverable 1.1:Conduct back up planningand several meetings with EDA responsible team for regulatory inspection.

· Deliverable 1.2: Desk review of all documents related to GMP inspection including legislations, regulations, guidelines, SOPs, and records.

· Deliverable 1.3: Conduct gap analysis and identify gaps and challenges to create a robust regulatory inspection system.

Output 2: Technically Support the revision of SOPs, guidelines related to regulatory inspections along with all procedural documents related to the same topic in EDA.
· Deliverable 2.1: Revise Draft SOPs/ guidelines/job descriptions and other GMP related documents in conjunction with EDA and verify the compliance of all drafted documents with WHO related guidelines.

· Deliverable 2.2: Provide technical advice after review and suggest modification in the final draft based on discussion and feedback from all stakeholders inside the EDA to seek their endorsement while engaging the Quality Department if needed.

Output3: Provide technical support to the EDA in GMP audits in Egypt and train inspectors on various GMP topics.
· Deliverable 3.1: Conduct coached GMP audits in 10 local producing companies in Egypt.

· Deliverable 3.2: Provide technical guidance to the inspectors in preparing for and conducting the GMP audit including CAPA implementation by the manufacturer.

· Deliverable 3.3: Train GMP inspectors from EDA on the following topics: classification of deficiencies, on how to write an inspection report, on the quality risk management, on the computerized system validation, on the inspection of QC/on the inspection of the HVAC/Data integrity/Sterile production/Investigational Skills/Evidence Based Inspection/communication and other GMP inspectors’ competencies.

· Deliverable 3.4: Review, evaluate and provide guidance on the GMP inspection reports.

Output 4Submit reports and final recommendations at the end of the consultancy contract.

· Deliverable 4.1: Submit 2 progress reports during the period of the contract.
· Deliverable 4.2: Submit comprehensive assignment report including executive summary, findings, and comprehensive detailed recommendations.

4. Qualifications, experience, skills and languages

Educational Qualifications:

Minimum first university degree for lower end of range, an advanced university degree for mid and high end of range, in a relevant field of pharmaceutical sciences and/or pharmaceutical production and/or pharmaceutical quality.

Experience:
5 to 10 years of relevant work experience in GMP inspection and regulatory systems related to different types of health technologies.

Skills/Technical skills and knowledge:

– Excellent skills in desk reviews, gap analysis, revising guidelines and SOPs and report writing skills

– Detailed understanding of FDA/ EMA/ WHO GMP guidelines.

– Experience in GMP regulatory inspections, GMP audit coaching

– Experience in developing training materials and conducting capacity building on GMP inspection
Languages and level required:
Fluent (Read – Write – Speak) English.

5. Location

The consultant will work in a hybrid format according to the needs of national. The Consultant will work between the field/ WHO CO Egypt and the desk review will be done through teleworking.

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