Pharmaceutical Products Quality Assurance Consultant (International)

Purpose of Activity/Assignment:
The purpose of this consultancy is to provide support in the implementation of pharmaceutical products procurement activities, with a focus on ensuring the procurement of high-quality medicines and medical supplies by UNICEF and its implementing partners for the Basic Package of Health Services (BPHS) and Essential Package of Hospital Services (EPHS). Additionally, the consultancy aims to enhance the overall supply chain management of the HER project.

UNICEF works in some of the world’s toughest places, to reach the world’s most disadvantaged children. To save their lives. To defend their rights. To help them fulfill their potential. 

Across 190 countries and territories, we work for every child, everywhere, every day, to build a better world for everyone. 

And we never give up. 

For every child, Deliver. 

https://www.youtube.com/watch?v=mbkJiMmvKqk

How can you make a difference? 

Scope of Work:

UNICEF Afghanistan Country Office has been collaborating with the Afghanistan Ministry of Public Health (MoPH) to enhance and sustain the availability of basic health services in the country. This is being achieved through the implementation of the Basic Package of Health Services (BPHS) and Essential Package of Hospital Services (EPHS). The main goal of this collaboration is to improve the quality of care, ensure equitable access to healthcare, and expand the range of services offered in the country.

Currently, UNICEF is managing the delivery of primary and secondary health services through the Health Emergency Response (HER) project. This is done through a contracted service provision model with Service Providers (SPs). The Service providers have specific objectives, which include managing the Basic Package of Health Services at primary healthcare facilities, including district hospitals, and managing the Essential Package of Hospital Services at provincial and regional hospitals. By working with these service providers, UNICEF aims to ensure the effective management and delivery of healthcare services at various levels of the healthcare system including the delivery of quality medicines.

One of the key components of the Health Emergency Response (HER) project is to ensure the availability of high-quality essential medicines and medical supplies at all levels, encompassing both the Basic Package of Health Services (BPHS) and Essential Package of Hospital Services (EPHS). This requires efficient management of pharmaceutical supplies and other medical resources to ensure their consistent availability. It also involves promoting the rational use of medicines, including appropriate prescription practices, and ensuring that patients utilize them correctly. By focusing on these aspects, the project aims to optimize the utilization of healthcare resources and enhance the overall quality of care provided.

The major tasks to be completed:

• Developing and implementing quality assurance procedures to ensure compliance of UNICEF and implementing partners with regulatory standards.
• Conducting assessment reviews and inspections to assess the quality systems and processes are in place.
• Reviewing and verifying documentation related to suppliers including manufacturers and wholesalers and importers of pharmaceutical products.
• Providing guidance and training to UNICEF implementing personnel involved in procurement and handling of pharmaceutical products on quality assurance practices and regulations.
• Assess quality-related issues of pharmaceutical products, including deviations, complaints, and non-conformities against the WHO and National Regulatory Authority Requirements.
• Collaborating with WHO and National Regulatory Authority in relation to pharmaceutical quality assurances activities.
• Keeping up to date with national regulatory requirements and procedures to ensure continuous compliance of UNICEF and implementing partners in all activities related to pharmaceutical products procurement and good storage and distribution practices (GSDP).

Work   Assignments Overview	Deliverables/Outputs	Delivery Deadline
Local procurement of pharmaceutical products
Activity 1.1: Identify the list of specific pharmaceutical products that need to be considered for local procurement.	1.1 List of pharmaceutical products selected for local procurement submitted.	31st March 2024 Working Days: 5
Activity 1.2: Conduct product specific market survey and evaluate the potential suppliers of pharmaceutical products, and check their National regulatory registration status, and conduct a thorough evaluation of their capabilities and compliance with the regulatory requirements.	1.2 Product specific market survey conducted for potential local suppliers, and report submitted.	30th June 2024 Working Days: 30
Activity 1.3: Collaborate with National Regulatory Authority and WHO: Work closely with National Regulatory Authority and WHO to gather all the necessary documents and information required for the product assessment for local procurement.	1.3 All the necessary document and information related to the product assessment collected and submitted.	30th June 2024 Working Days: 9
Activity 1.4: Prepare Documentation and Application: Prepare all the required documentation, including product registration certificates, quality control documentation, and any other necessary paperwork. Accurately fill out the application form provided by UNICEF-SD to request for local procurement authorization for the selected pharmaceutical products.	1.4 Application document that filled correctly prepared and submitted with all the required documents.	31st August 2024 Working Days: 30
Pharmaceutical products procured by UNICEF Implementing partners meet the required quality standards.
Activity 2.1: Identify and outline the quality requirements and standards set by National Regulatory Authority, WHO/UNICEF for the local procurement of quality pharmaceutical products	2.1 The requirements and standards set by National Regulatory Authority, WHO/UNICEF for the quality assurance and control of the local procurement of pharmaceutical products described and submitted.	30th March 2024 Working Days: 10
Activity 2.2: Ensure that all pharmaceutical products procured locally by UNICEF Afghanistan Country Office and/or implementing partner meet the required standards and specifications set by National Regulatory Authority, WHO/UNICEF.	2.2 Submission of assessment report with the detail specifications that aligned with the standards for all pharmaceutical products procured by UNICEF implementing partner.	From April 2024 up to the end of the contract Working Days: 15
Activity 2.3: Monitor the compliance of UNICEF Implementing partners with National Regulatory Authority and WHO/UNICEF requirements, as well as their adherence to the UNICEF Standard Operating Procedure (SoP) outline the quality requirement for the pharmaceutical procurement.	2.3 Submission of report on the verification of compliance of UNICEF Implementing partners with the requirements of the National Regulatory Authority and WHO/UNICEF as well as the UNICEF Standard Operating Procedure (SoP).	From April 2024 up to the end of the contract Working Days: 15
Activity 2.4: Maintain a copy of all documentation for the registration and importation of all pharmaceutical products procured locally by UNICEF and UNICEF Implementing Partners.	2.4 A soft and hard copies of registration and importation documents submitted by suppliers are kept at UNICEF Afghanistan Country Office for all pharmaceutical products procured by UNICEF and UNICEF Implementing Partners.	From April 2024 up to the end of the contract Working Days: 14
Activity 2.5: Verify that the documents submitted by the local supplier for the specific pharmaceutical products adhere to the requirement of the National Regulatory Authority and WHO and the local suppliers are registered in Afghanistan. Additionally, ensure that these documents are authenticated by the National Regulatory Authority.	2.4   2.5 (a). All documents submitted by the local suppliers are verified and authenticated by National regulatory authority. (b) All local suppliers from whom the UNICEF implementing partners procure pharmaceutical products are registered by National Regulatory Authority.	From April 2024 up to the end of the contract Working Days: 10
Monitoring
Activity 3.1: Conduct regular monitoring at central, provincial and health facility levels of UNICEF implementing partners to ensure compliance with quality assurance and Good Storage and Distribution Practice (GSDP) using the UNICEF Pharmaceutical products management and quality assurance check list which is attached to the Standard Operating Procedure (SoP).	3.1 Submission of Monitoring report.	From April 2024 up to the end of the contract Working Days: 60
Activity 3.2: Conduct routine sample evaluation (physical quality check including assessing the package, physical appearance, and batch numbers) for pharmaceutical products delivered from different suppliers and asses the handling, storage, distribution, and proper recorded in the inventory control system.	3.2 Develop a tracking tool and submit reports for the sample evaluation of selected pharmaceutical products.	From April 2024 up to the end of the contract Working Days: 30
Capacity building
Activity 4.1: Develop a training program in collaboration with WHO and local partners focused on pharmaceutical quality assurance system for Service providers and organize and provide the training sessions.	4.1 Training program developed and provided on pharmaceutical quality assurance system for UNICEF implementing partners.	Quarterly: From April 2024 up to the end of the contract Working Days: 15
Activity 4.2: Provide on the job training to UNICEF implementing partners staff members, specifically on pharmaceutical products management and quality assurance.	4.2 Customized on-the-job training provided for the specific implementing partner.	From April 2024 up to the end of the contract Working Days: 0
Activity 4.3: Organize experiences and best practices sharing sessions between SPs.	4.3 Facilitation of knowledge sharing and submission of report on best practices sharing sessions conducted among UNICEF implementing partners.	Quarterly: From April 2024 up to the end of the contract Working Days: 10
Coordination with National Regulatory Authority and WHO.
Activity 5.1: Establish regular communication with the National Regulatory Authority for updated procedures and requirement and closely work with them to ensure the quality assurance of pharmaceutical products procured locally.	5.1 Regular communications, meetings, and sessions with the National Regulatory Authority, WHO and other local partners are established in relation to quality assurance of local procurement.	From April 2024 up to the end of the contract Working Days: 9
Activity 5.2: Collaborate with WHO on the capacity building initiatives aimed to enhance National Regulatory Authorities capabilities in quality assurance.	5.2 Report on capacity building activities conducted in collaboration with WHO.	Quarterly: From April 2024 up to the end of the contract Working Days: 9

To qualify as an advocate for every child you will have… 

• An advanced university degree (Bachelor’s or higher) in pharmacy. 
  * A university bachelor’s degree in pharmacy with a minimum of 6 years of experiences or a master’s degree in pharmacy or quality assurance with a minimum of 5 years of work experience.
• Experience working in the pharmaceutical sector and regulatory authority Preferably in Quality assurance, GMP and GSDP.
• Familiarity with Health System and medicine quality and safety. Familiarity with Afghanistan quality and safety standard would be an added advantage.
• Excellent pharmaceutical analytical skills.
• Work experience with governments and development partners.
• Excellent verbal and written communication systems.
• Excellent interpersonal and communication skills.
• High sense of responsibility and strong organizational skills with ability to work under pressure.
• Advanced computer literacy (Word, Excel, Power point, etc.).

Language requirements:

• Excellent knowledge of English (oral & written).
• Knowledge of Pashtu and Dari would be an advantage.

For every Child, you demonstrate… 

UNICEF’s values of Care, Respect, Integrity, Trust, Accountability, and Sustainability (CRITAS). 

 To view our competency framework, please visit here. 

UNICEF is here to serve the world’s most disadvantaged children and our global workforce must reflect the diversity of those children. The UNICEF family is committed to include everyone, irrespective of their race/ethnicity, age, disability, gender identity, sexual orientation, religion, nationality, socio-economic background, or any other personal characteristic.

UNICEF offers reasonable accommodation for consultants/individual contractors with disabilities. This may include, for example, accessible software, travel assistance for missions or personal attendants. We encourage you to disclose your disability during your application in case you need reasonable accommodation during the selection process and afterwards in your assignment. 

UNICEF has a zero-tolerance policy on conduct that is incompatible with the aims and objectives of the United Nations and UNICEF, including sexual exploitation and abuse, sexual harassment, abuse of authority and discrimination. UNICEF also adheres to strict child safeguarding principles. All selected candidates will be expected to adhere to these standards and principles and will therefore undergo rigorous reference and background checks. Background checks will include the verification of academic credential(s) and employment history. Selected candidates may be required to provide additional information to conduct a background check. 

Remarks:  

Interested consultants are required to apply online, indicating availability and all-inclusive lump sum fee to undertake the terms of reference.

Only shortlisted candidates will be contacted and advance to the next stage of the selection process. 

Individuals engaged under a consultancy or individual contract will not be considered “staff members” under the Staff Regulations and Rules of the United Nations and UNICEF’s policies and procedures and will not be entitled to benefits provided therein (such as leave entitlements and medical insurance coverage). Their conditions of service will be governed by their contract and the General Conditions of Contracts for the Services of Consultants and Individual Contractors. Consultants and individual contractors are responsible for determining their tax liabilities and for the payment of any taxes and/or duties, in accordance with local or other applicable laws. 

The selected candidate is solely responsible to ensure that the visa (applicable) and health insurance required to perform the duties of the contract are valid for the entire period of the contract. Selected candidates are subject to confirmation of fully vaccinated status against SARS-CoV-2 (Covid-19) with a World Health Organization (WHO)-endorsed vaccine, which must be met prior to taking up the assignment. It does not apply to consultants who will work remotely and are not expected to work on or visit UNICEF premises, programme delivery locations or directly interact with communities UNICEF works with, nor to travel to perform functions for UNICEF for the duration of their consultancy contracts.