The consultant/vendor will provide technical assistance to the Committee for Medical and Pharmaceutical Control (committee) to establish a Quality management system (QMS). The committee is responsible for management and implementation of the state policy, control, and surveillance, circulation of medicines, and medical devices. The committee also oversees the national MRA. One of the gaps identified during the Global Benchmarking Tool (GBT) [1]assessment was that the committee needs to establish a QMS, ISO 9001:2015[2]. The consultant/vendor will provide technical assistance to the committee to establish QMS by assessing the status, identifying gaps, and providing technical input in addressing the gaps.
The consultant/vendor will work within a dynamic, fast-paced environment. The consultant/ vendor will liaise with national counterparts, and PQM+ staff, and consultants to implement the activities, ensuring high-quality project deliverables in compliance with all USP and USAID requirements.
Key Responsibilities
· Assess the QMS of the committee against ISO 9001:2015 requirements
· Develop a report documenting the findings from the assessment
· Develop an action plan to address the gaps identified in the assessment
· Provide technical input in drafting of mandatory ISO 9001 procedures, policies, quality objectives, operating forms, and guidelines
· Train committee staff to drive implementation of ISO 9001 and build capacity of internal auditors with issuance of international certification.
· Provide technical input in the identification of indicators to measure the progress in ISO 9001
· Provide technical assistance during accreditation assessment for ISO 9001 for example helping respond to questions from the accredit
· Provide technical assistance in developing and responding to corrective and preventive action plan (CAPA)
Deliverables
· Assessment report on QMS against the ISO 9001:2015 requirements
· Action plan to assess the gaps against the ISO 9001:2015 requirements
· Procedures, policies, and guidelines to meet the ISO 9001:2015 requirements
· Training material and report to meet the ISO 9001:2015 requirements
· Performance indicators to measure the progress against ISO 9001:2015 requirements
Qualifications
· ISO 9001:2015 approved Management Systems Certification body
· Minimum of ten (10) years’ experience with track record of back-to-back certification, surveillance, and recertification support to clients.
· Excellent skills in communication and report writing.
· Fluency in English and Russian.
Period of Performance
The period of performance for this consultancy will begin November 22, 2021, and end September 30, 2022.
How to apply
Please send CV, 3-References, and Hourly Rate in US$ to ATTN: Masoud Azam, Senior Procurement Specialist, at GPH_Procurement@USP.org by the closing date of November 19, 2021 When submitting your application, write “International Organization for Standardization Consultant - Kazakhstan” in the email Subject Line.
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries. USP’s focus on global public health extends to lower and middle-income countries with work in over 20 countries through donor-funded programs. Our programs are focused on building the capacity of regulatory authorities and manufacturers in ensuring patient access to quality-assured essential medicines by providing: 1) technical assistance to manufacturers to increase the supply of quality-assured priority medicines for malaria, HIV/AIDS, tuberculosis (TB), neglected tropical diseases (NTDs), and maternal, newborn, and child health (MNCH) products; and 2) capacity-building activities to regulatory authorities to fulfill their function in ensuring the supply of quality-assured medical products.
Promoting the Quality of Medicines Plus (PQM+) is a USAID-funded, USP-implemented cooperative agreement which includes objectives to strengthen pharmaceutical quality assurance policies, optimize financial resources for medical product quality assurance and to increase the supply of quality-assured essential medical products of public health importance. PQM+ is working in Kazakhstan with the Committee and the Medicines Regulatory Authority (MRA) to improve the quality of medical products in public and private sectors.
