Good manufacturing practices consultancy to support National Regulatory Authority

Overview

Support the National Regulatory Authority in enhancing GMP inspections and compliance.

You have:

• Minimum first university degree in a relevant field of pharmaceutical sciences, advanced degree preferred.
• 5 to 10 years of relevant work experience in GMP inspection and regulatory systems related to different types of health technologies.
• Fluent (Read - Write - Speak) in English.
• Excellent skills in desk reviews, gap analysis, revising guidelines and SOPs, and report writing.
• Understanding of FDA/EMA/WHO GMP guidelines.
• Experience in conducting GMP audits and coaching auditors.
• Experience in developing training materials and conducting capacity building on GMP inspection.

1. Purpose of consultancy

The main objective of this consultancy is to enhance the GMP inspection function in the NRA to ensure the compliance of the regulatory authority performance with PIC/S standards and WHO standards.

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, 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 NRA 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 in September 2023.

In this context, and as per the political will to transform Egypt into a manufacturing hub in the region, the NRA is requesting a GMP consultant a GMP consultant to work with the team on activities related to inspections on manufacturers to comply with PIC/S and WHO standards.

3. Work to be performed

To achieve the above purpose, the consultant will be contracted with the following deliverables:

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

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

· Deliverable 1.2: Desk review of all documents related to GMP inspection including legislations, 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 NRA to seek their endorsement while engaging the Quality Department if needed.

Output 3: Revise the Regulatory Inspection (RI) function in the GBT with NRA responsible team

· Deliverable 3.1: Revise all indicators and sub indicators in the tool related to the RI function

· Deliverable 3.2: provide solutions and recommendations for any gaps found to ensure the compliance of the regulatory inspection system with standards of PIC/S and WHO recommendations.

Output4: Provide technical support to the NRA in GMP audits in Egypt and train inspectors on various GMP topics.

· Deliverable 4.1: Conduct coached GMP audits in 10 local producing companies in Egypt.

· Deliverable 4.2: Provide technical guidance to the inspectors in preparing for and conducting the GMP audit including CAPA implementation by the manufacturer.

· Deliverable 4.3: Train GMP inspectors from NRA 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 4.4: Review, evaluate and provide guidance on the GMP inspection reports

Output 5: Submit reports and final recommendations at the end of the consultancy contract.

· Deliverable 5.1: Submit 2 progress reports during the period of the contract.

· Deliverable 5.2: 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 filed 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) in English

5. Location

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

6. Planned timelines (Subject to confirmation)

(part time consultancy total of 70 working days subject to confirmation)

Start Date: 1st of November 2023

End Date: 30th 0f April 2024

7. Medical clearance

The selected Consultant will be expected to provide a medical certificate of fitness for work.

8. Travel

The consultant is expected to travel.

Additional Information

· This vacancy notice may be used to identify candidates for other similar consultancies at the same level.

• Only candidates under serious consideration will be contacted.
• A written test may be used as a form of screening.
• If your candidature is retained for interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/. Some professional certificates may not appear in the WHED and will require individual review.
• For information on WHO's operations please visit: http://www.who.int.

· The WHO is committed to creating a diverse and inclusive environment of mutual respect. The WHO recruits workforce regardless of disability status, sex, gender identity, sexual orientation, language, race, marital status, religious, cultural, ethnic and socio-economic backgrounds, or any other personal characteristics.

The WHO is committed to achieving gender parity and geographical diversity in its workforce. Women, persons with disabilities, and nationals of unrepresented and underrepresented Member States (https://www.who.int/careers/diversity-equity-and-inclusion) are strongly encouraged to apply for WHO jobs.

Persons with disabilities can request reasonable accommodations to enable participation in the recruitment process. Requests for reasonable accommodation should be sent through an email to reasonableaccommodation@who.int

· An impeccable record for integrity and professional ethical standards is essential. WHO prides itself on a workforce that adheres to the highest ethical and professional standards and that is committed to put the WHO Values Charter (https://www.who.int/about/who-we-are/our-values) into practice.

• WHO has zero tolerance towards sexual exploitation and abuse (SEA), sexual harassment and other types of abusive conduct (i.e., discrimination, abuse of authority and harassment). All members of the WHO workforce have a role to play in promoting a safe and respectful workplace and should report to WHO any actual or suspected cases of SEA, sexual harassment and other types of abusive conduct. To ensure that individuals with a substantiated history of SEA, sexual harassment or other types of abusive conduct are not hired by the Organization, WHO will conduct a background verification of short-listed candidates.
• WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
• Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority.
• WHO shall have no responsibility for any taxes, duties, social security contributions or other contributions payable by the Consultant. The Consultant shall be solely responsible for withholding and paying any taxes, duties, social security contributions and any other contributions which are applicable to the Consultant in each location/jurisdiction in which the work hereunder is performed, and the Consultant shall not be entitled to any reimbursement thereof by WHO.
• Please note that WHO’s contracts are conditional on members of the workforce confirming that they are vaccinated as required by WHO before undertaking a WHO assignment, except where a medical condition does not allow such vaccination, as certified by the WHO Staff Health and Wellbeing Services (SHW). The successful candidate will be asked to provide relevant evidence related to this condition. A copy of the updated vaccination card must be shared with WHO medical service in the medical clearance process. Please note that certain countries require proof of specific vaccinations for entry or exit. For example, official proof /certification of yellow fever vaccination is required to enter many countries. Country-specific vaccine recommendations can be found on the WHO international travel and Staff Health and Wellbeing website. For vaccination-related queries please directly contact SHW directly at [email protected].
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Added 2 years ago - Updated 1 year ago - Source: who.int