Pharmaceutical Products Quality Assurance Consultant (International)

UNICEF works in a number of the world’s hardest locations, to succeed in the world’s most deprived youngsters. To save lots of their lives. To defend their rights. To assist them fulfill their potential. 

Throughout 190 nations and territories, we work for each youngster, in every single place, on daily basis, to construct a greater world for everybody. 

And we by no means hand over. 

For each youngster, Ship. 

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

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 boost and maintain the provision of fundamental well being providers within the nation. That is being achieved via the implementation of the Primary Bundle of Well being Companies (BPHS) and Important Bundle of Hospital Companies (EPHS). The principle purpose of this collaboration is to enhance the standard of care, guarantee equitable entry to healthcare, and increase the vary of providers provided within the nation.

At the moment, UNICEF is managing the supply of main and secondary well being providers via the Well being Emergency Response (HER) mission. That is executed via a contracted service provision mannequin with Service Suppliers (SPs). The Service suppliers have particular targets, which embody managing the Primary Bundle of Well being Companies at main healthcare amenities, together with district hospitals, and managing the Important Bundle of Hospital Companies at provincial and regional hospitals. By working with these service suppliers, UNICEF goals to make sure the efficient administration and supply of healthcare providers 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 Companies (BPHS) and Important Bundle of Hospital Companies (EPHS). This requires environment friendly administration of pharmaceutical provides and different medical sources to make sure their constant availability. It additionally includes 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 sources and improve the general high quality of care offered.

The foremost duties to be accomplished:

• Creating and implementing high quality assurance procedures to make sure compliance of UNICEF and implementing companions with regulatory requirements.
• Conducting evaluation evaluations and inspections to evaluate the standard programs and processes are in place.
• Reviewing and verifying documentation associated to suppliers together with producers and wholesalers and importers of pharmaceutical merchandise.
• Offering steerage and coaching to UNICEF implementing personnel concerned in procurement and dealing with of pharmaceutical merchandise on high quality assurance practices and rules.
• 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.
• Retaining 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 checklist of particular pharmaceutical merchandise that should be thought of for native procurement.	1.1 Record 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 test their Nationwide regulatory registration standing, and conduct a radical 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 intently with Nationwide Regulatory Authority and WHO to collect all the required paperwork and data required for the product evaluation for native procurement.	1.3 All the required doc and data 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 another obligatory paperwork. Precisely fill out the applying 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 regionally by UNICEF Afghanistan Nation Workplace and/or implementing companion 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 companion.	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 Commonplace 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 Commonplace Working Process (SoP).	From April 2024 as much as the tip of the contract Working Days: 15
Exercise 2.4: Keep a duplicate of all documentation for the registration and importation of all pharmaceutical merchandise procured regionally by UNICEF and UNICEF Implementing Companions.	2.4 A comfortable and onerous 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 precise pharmaceutical merchandise adhere to the requirement of the Nationwide Regulatory Authority and WHO and the native suppliers are registered in Afghanistan. Moreover, be certain 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 Follow (GSDP) utilizing the UNICEF Pharmaceutical merchandise administration and high quality assurance test checklist which is hooked up to the Commonplace 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 test together with assessing the package deal, bodily look, and batch numbers) for pharmaceutical merchandise delivered from totally 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 experiences 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 targeted on pharmaceutical high quality assurance system for Service suppliers and arrange and supply the coaching periods.	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 employees members, particularly on pharmaceutical merchandise administration and high quality assurance.	4.2 Custom-made on-the-job coaching offered for the precise implementing companion.	From April 2024 as much as the tip of the contract Working Days: 0
Exercise 4.3: Manage experiences and finest practices sharing periods between SPs.	4.3 Facilitation of information sharing and submission of report on finest practices sharing periods 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 intently work with them to make sure the standard assurance of pharmaceutical merchandise procured regionally.	5.1 Common communications, conferences, and periods 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 boost 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 youngster you should have… 

• A complicated college diploma (Bachelor’s or larger) 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 medication high quality and security. Familiarity with Afghanistan high quality and security commonplace could be an added benefit.
• Wonderful pharmaceutical analytical abilities.
• Work expertise with governments and growth companions.
• Wonderful verbal and written communication programs.
• Wonderful interpersonal and communication abilities.
• Excessive sense of accountability and robust organizational abilities with capacity to work underneath stress.
• Superior pc literacy (Phrase, Excel, Energy level, and so on.).

Language necessities:

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

For each Baby, you display… 

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 youngsters and our world workforce should mirror the range of these youngsters. The UNICEF family is committed to include everyone, no matter their race/ethnicity, age, incapacity, gender identification, sexual orientation, faith, nationality, socio-economic background, or another private attribute.

UNICEF presents reasonable accommodation for consultants/particular person contractors with disabilities. This will embody, 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 cheap lodging through 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 youngster safeguarding ideas. All chosen candidates shall be anticipated to stick to those requirements and ideas and can subsequently bear rigorous reference and background checks. Background checks will embody the verification of educational credential(s) and employment historical past. Chosen candidates could also be required to supply extra data to conduct a background test. 

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 shall be contacted and advance to the following stage of the choice course of. 

People engaged underneath a consultancy or particular person contract won’t be thought of “employees members” underneath the Employees Rules and Guidelines of the United Nations and UNICEF’s insurance policies and procedures and won’t be entitled to advantages offered therein (similar to depart entitlements and medical insurance coverage protection). Their situations of service shall be ruled by their contract and the Normal Situations of Contracts for the Companies of Consultants and Particular person Contractors. Consultants and particular person contractors are answerable 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 totally vaccinated standing towards SARS-CoV-2 (Covid-19) with a World Well being Group (WHO)-endorsed vaccine, which should be met previous to taking over the task. It doesn’t apply to consultants who will work remotely and are usually not anticipated to work on or go to UNICEF premises, programme supply areas or immediately work together with communities UNICEF works with, nor to journey to carry out capabilities for UNICEF all through their consultancy contracts.