Pharmaceutical Products Quality Assurance Consultant (National)

UNICEF works in among the world’s hardest locations, to achieve the world’s most deprived kids. To avoid wasting their lives. To defend their rights. To assist them fulfill their potential. 

Throughout 190 international locations and territories, we work for each baby, in all places, day by day, to construct a greater world for everybody. 

And we by no means quit. 

For each baby, Ship.

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

How are you going to make a distinction? 

How are you going to make a distinction? 

Scope of Work:

UNICEF Afghanistan Nation Workplace has been collaborating with the Afghanistan Ministry of Public Well being (MoPH) to reinforce and maintain the provision of fundamental well being companies within the nation. That is being achieved by means of the implementation of the Primary Bundle of Well being Providers (BPHS) and Important Bundle of Hospital Providers (EPHS). The primary objective of this collaboration is to enhance the standard of care, guarantee equitable entry to healthcare, and broaden the vary of companies provided within the nation.

At present, UNICEF is managing the supply of major and secondary well being companies by means of the Well being Emergency Response (HER) mission. That is executed by means of a contracted service provision mannequin with Service Suppliers (SPs). The Service suppliers have particular targets, which embrace managing the Primary Bundle of Well being Providers at major healthcare services, together with district hospitals, and managing the Important Bundle of Hospital Providers at provincial and regional hospitals. By working with these service suppliers, UNICEF goals to make sure the efficient administration and supply of healthcare companies at numerous ranges of the healthcare system together with the supply of high quality medicines.

One of many key elements of the Well being Emergency Response (HER) mission is to make sure the provision of high-quality important medicines and medical provides in any respect ranges, encompassing each the Primary Bundle of Well being Providers (BPHS) and Important Bundle of Hospital Providers (EPHS). This requires environment friendly administration of pharmaceutical provides and different medical assets to make sure their constant availability. It additionally entails selling the rational use of medicines, together with applicable prescription practices, and guaranteeing that sufferers make the most of them accurately. By specializing in these elements, the mission goals to optimize the utilization of healthcare assets and improve the general high quality of care offered.

The foremost duties to be accomplished:

• Growing and implementing high quality assurance procedures to make sure compliance of UNICEF and implementing companions with regulatory requirements.
• Conducting evaluation opinions and inspections to evaluate the standard methods and processes are in place.
• Reviewing and verifying documentation associated to suppliers together with producers and wholesalers and importers of pharmaceutical merchandise.
• Offering steering and coaching to UNICEF implementing personnel concerned in procurement and dealing with of pharmaceutical merchandise on high quality assurance practices and laws.
• Assess quality-related problems with pharmaceutical merchandise, together with deviations, complaints, and non-conformities towards the WHO and Nationwide Regulatory Authority Necessities.
• Collaborating with WHO and Nationwide Regulatory Authority in relation to pharmaceutical high quality assurances actions.
• Protecting updated with nationwide regulatory necessities and procedures to make sure steady compliance of UNICEF and implementing companions in all actions associated to pharmaceutical merchandise procurement and good storage and distribution practices (GSDP).

Work   Assignments Overview	Deliverables/Outputs	Supply Deadline
Native procurement of pharmaceutical merchandise
Exercise 1.1: Establish the record of particular pharmaceutical merchandise that should be thought-about for native procurement.	1.1 Checklist of pharmaceutical merchandise chosen for native procurement submitted.	31st March 2024 Working Days: 5
Exercise 1.2: Conduct product particular market survey and consider the potential suppliers of pharmaceutical merchandise, and verify their Nationwide regulatory registration standing, and conduct an intensive analysis of their capabilities and compliance with the regulatory necessities.	1.2 Product particular market survey performed for potential native suppliers, and report submitted.	30th June 2024 Working Days: 30
Exercise 1.3: Collaborate with Nationwide Regulatory Authority and WHO: Work carefully with Nationwide Regulatory Authority and WHO to collect all the mandatory paperwork and knowledge required for the product evaluation for native procurement.	1.3 All the mandatory doc and knowledge associated to the product evaluation collected and submitted.	30th June 2024 Working Days: 9
Exercise 1.4: Put together Documentation and Software: Put together all of the required documentation, together with product registration certificates, high quality management documentation, and some other obligatory paperwork. Precisely fill out the appliance type offered by UNICEF-SD to request for native procurement authorization for the chosen pharmaceutical merchandise.	1.4 Software doc that crammed accurately ready and submitted with all of the required paperwork.	31st August 2024 Working Days: 30
Pharmaceutical merchandise procured by UNICEF Implementing companions meet the required high quality requirements.
Exercise 2.1: Establish and description the standard necessities and requirements set by Nationwide Regulatory Authority, WHO/UNICEF for the native procurement of high quality pharmaceutical merchandise	2.1 The necessities and requirements set by Nationwide Regulatory Authority, WHO/UNICEF for the standard assurance and management of the native procurement of pharmaceutical merchandise described and submitted.	30th March 2024 Working Days: 10
Exercise 2.2: Make sure that all pharmaceutical merchandise procured domestically by UNICEF Afghanistan Nation Workplace and/or implementing associate meet the required requirements and specs set by Nationwide Regulatory Authority, WHO/UNICEF.	2.2 Submission of evaluation report with the element specs that aligned with the requirements for all pharmaceutical merchandise procured by UNICEF implementing associate.	From April 2024 as much as the tip of the contract Working Days: 15
Exercise 2.3: Monitor the compliance of UNICEF Implementing companions with Nationwide Regulatory Authority and WHO/UNICEF necessities, in addition to their adherence to the UNICEF Normal Working Process (SoP) define the standard requirement for the pharmaceutical procurement.	2.3 Submission of report on the verification of compliance of UNICEF Implementing companions with the necessities of the Nationwide Regulatory Authority and WHO/UNICEF in addition to the UNICEF Normal Working Process (SoP).	From April 2024 as much as the tip of the contract Working Days: 15
Exercise 2.4: Preserve a replica of all documentation for the registration and importation of all pharmaceutical merchandise procured domestically by UNICEF and UNICEF Implementing Companions.	2.4 A comfortable and exhausting copies of registration and importation paperwork submitted by suppliers are saved at UNICEF Afghanistan Nation Workplace for all pharmaceutical merchandise procured by UNICEF and UNICEF Implementing Companions.	From April 2024 as much as the tip of the contract Working Days: 14
Exercise 2.5: Confirm that the paperwork submitted by the native provider for the particular pharmaceutical merchandise adhere to the requirement of the Nationwide Regulatory Authority and WHO and the native suppliers are registered in Afghanistan. Moreover, be sure that these paperwork are authenticated by the Nationwide Regulatory Authority.	2.4   2.5 (a). All paperwork submitted by the native suppliers are verified and authenticated by Nationwide regulatory authority. (b) All native suppliers from whom the UNICEF implementing companions procure pharmaceutical merchandise are registered by Nationwide Regulatory Authority.	From April 2024 as much as the tip of the contract Working Days: 10
Monitoring
Exercise 3.1: Conduct common monitoring at central, provincial and well being facility ranges of UNICEF implementing companions to make sure compliance with high quality assurance and Good Storage and Distribution Apply (GSDP) utilizing the UNICEF Pharmaceutical merchandise administration and high quality assurance verify record which is hooked up to the Normal Working Process (SoP).	3.1 Submission of Monitoring report.	From April 2024 as much as the tip of the contract Working Days: 60
Exercise 3.2: Conduct routine pattern analysis (bodily high quality verify together with assessing the bundle, bodily look, and batch numbers) for pharmaceutical merchandise delivered from completely different suppliers and asses the dealing with, storage, distribution, and correct recorded within the stock management system.	3.2 Develop a monitoring software and submit reviews for the pattern analysis of chosen pharmaceutical merchandise.	From April 2024 as much as the tip of the contract Working Days: 30
Capability constructing
Exercise 4.1: Develop a coaching program in collaboration with WHO and native companions centered on pharmaceutical high quality assurance system for Service suppliers and set up and supply the coaching classes.	4.1 Coaching program developed and offered on pharmaceutical high quality assurance system for UNICEF implementing companions.	Quarterly: From April 2024 as much as the tip of the contract Working Days: 15
Exercise 4.2: Present on the job coaching to UNICEF implementing companions workers members, particularly on pharmaceutical merchandise administration and high quality assurance.	4.2 Personalized on-the-job coaching offered for the particular implementing associate.	From April 2024 as much as the tip of the contract Working Days: 0
Exercise 4.3: Set up experiences and finest practices sharing classes between SPs.	4.3 Facilitation of data sharing and submission of report on finest practices sharing classes performed amongst UNICEF implementing companions.	Quarterly: From April 2024 as much as the tip of the contract Working Days: 10
Coordination with Nationwide Regulatory Authority and WHO.
Exercise 5.1: Set up common communication with the Nationwide Regulatory Authority for up to date procedures and requirement and carefully work with them to make sure the standard assurance of pharmaceutical merchandise procured domestically.	5.1 Common communications, conferences, and classes with the Nationwide Regulatory Authority, WHO and different native companions are established in relation to high quality assurance of native procurement.	From April 2024 as much as the tip of the contract Working Days: 9
Exercise 5.2: Collaborate with WHO on the capability constructing initiatives aimed to reinforce Nationwide Regulatory Authorities capabilities in high quality assurance.	5.2 Report on capability constructing actions performed in collaboration with WHO.	Quarterly: From April 2024 as much as the tip of the contract Working Days: 9

To qualify as an advocate for each baby you should have… 

• A sophisticated college diploma (Bachelor’s or greater) in pharmacy.   
  * A college bachelor’s diploma in pharmacy with a minimal of 6 years of experiences or a grasp’s diploma in pharmacy or high quality assurance with a minimal of 5 years of labor expertise. 
• Expertise working within the pharmaceutical sector and regulatory authority Ideally in High quality assurance, GMP and GSDP.
• Familiarity with Well being System and drugs high quality and security. Familiarity with Afghanistan high quality and security commonplace could be an added benefit.
• Wonderful pharmaceutical analytical expertise.
• Work expertise with governments and improvement companions.
• Wonderful verbal and written communication methods.
• Wonderful interpersonal and communication expertise.
• Excessive sense of accountability and robust organizational expertise with potential to work below strain.
• Superior pc literacy (Phrase, Excel, Energy level, and so on.).

Language necessities:

• Wonderful information of English (oral & written).
• Information of Pashtu and Dari could be a bonus.

For each Youngster, you show… 

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

 To view our competency framework, please go to here. 

UNICEF is right here to serve the world’s most deprived kids and our world workforce should mirror the range of these kids. The UNICEF family is committed to include everyone, regardless of their race/ethnicity, age, incapacity, gender identification, sexual orientation, faith, nationality, socio-economic background, or some other private attribute.

UNICEF provides reasonable accommodation for consultants/particular person contractors with disabilities. This will embrace, for instance, accessible software program, journey help for missions or private attendants. We encourage you to reveal your incapacity throughout your software in case you want affordable lodging throughout the choice course of and afterwards in your task. 

UNICEF has a zero-tolerance coverage on conduct that’s incompatible with the goals and targets of the United Nations and UNICEF, together with sexual exploitation and abuse, sexual harassment, abuse of authority and discrimination. UNICEF additionally adheres to strict baby safeguarding rules. All chosen candidates might be anticipated to stick to those requirements and rules and can due to this fact endure rigorous reference and background checks. Background checks will embrace the verification of educational credential(s) and employment historical past. Chosen candidates could also be required to supply extra info to conduct a background verify. 

Remarks:  

consultants are required to use on-line, indicating availability and all-inclusive lump sum price to undertake the phrases of reference.

Solely shortlisted candidates might be contacted and advance to the following stage of the choice course of. 

People engaged below a consultancy or particular person contract is not going to be thought-about “workers members” below the Workers Laws and Guidelines of the United Nations and UNICEF’s insurance policies and procedures and won’t be entitled to advantages offered therein (resembling go away entitlements and medical insurance coverage protection). Their circumstances of service might be ruled by their contract and the Basic Situations of Contracts for the Providers of Consultants and Particular person Contractors. Consultants and particular person contractors are chargeable for figuring out their tax liabilities and for the fee of any taxes and/or duties, in accordance with native or different relevant legal guidelines. 

The chosen candidate is solely accountable to make sure that the visa (relevant) and medical insurance required to carry out the duties of the contract are legitimate for your complete interval of the contract. Chosen candidates are topic to affirmation of absolutely vaccinated standing towards SARS-CoV-2 (Covid-19) with a World Well being Group (WHO)-endorsed vaccine, which have to be met previous to taking over the task. It doesn’t apply to consultants who will work remotely and aren’t anticipated to work on or go to UNICEF premises, programme supply places or straight work together with communities UNICEF works with, nor to journey to carry out capabilities for UNICEF at some stage in their consultancy contracts.