Job Description
Duties and Responsibilities
The incumbent will work under overall supervision of Project Manager and direct supervision of Procurement and Supply Chain Management Specialist.
The Pharmaceutical Analyst will be responsible for conducting quality assurance and compliance checks on pharmaceuticals and health products procured under the Global Fund programme in Nepal. The role involves reviewing pharmaceutical data, monitoring supply chains in coordination with the Procurement and Supply Chain Management Analyst and ensuring adherence to national and international drug regulations. The Pharmaceutical Analyst will collaborate with government agencies, suppliers, and health institutions to ensure the safe distribution of quality-assured medicines across Nepal.
Quality assurance of Health Products:
- Ensure laboratory analysis and testing of pharmaceutical products is conducted to meet national and international quality standards (WHO prequalification, Good Manufacturing Practices (GMP) compliance under the Global Fund grant.
- Review Certificates of Analysis (CoA) from suppliers and ensure products comply with specifications.
- Coordinate with Department of Drug Administration to identify and report substandard, falsified, or counterfeit medicines.
Procurement of Health Products:
- Collaborate with the procurement team to review and verify Health product specifications.
- Collaborate with Procurement Analyst, Logistic Analyst, Lab Analyst to monitor the storage, transportation, and distribution of Health Products to ensure compliance with Good Distribution Practices (GDP).
- Ensure proper documentation and reporting of Health Products throughout the supply chain in collaboration with the Procurement and Supply Chain Management Analyst.
Regulatory Compliance & Risk Management:
- Stay updated with WHO guidelines and Global Fund policies on Health Products quality assurance and update the team accordingly.
- Support the registration of new Health products as required by the project.
- Identify risks in the Health Products supply chain and recommend mitigation strategies.
- Prepare reports on pharmaceutical quality assessments, including testing outcomes and risk analysis under GC7 grant.
- Maintain proper documentation of all Health products -related activities for audits and reviews.
Stakeholder Engagement:
- Liaise with government agencies, laboratories, suppliers, and partners to ensure a coordinated approach to Health Products quality assurance.
- Provide technical assistance to stakeholders on quality assurance protocols.
- Support capacity building initiatives to Government Stakeholders.
Facilitation of knowledge building:
- Ensures facilitation of knowledge building and knowledge sharing to relevant stakeholders including country office. Assist in synthesis of lessons learnt and best practices to contribute to strengthening of national supply chain management.
- Interacts with and provides guidance for national partners and independent experts on developing adequate specifications for goods and services in line with the UNDP rules and procedures and review and adjustment as needed.
Contribution towards Gender and Social Inclusion (GESI)
- Promote a safe working environment by developing respectful and safe organizational culture and supporting practices.
- Collaborate with team members, programme partners, and sub-recipients to ensure safe implementation of programmes at the community level applying Do No Harm approach.
- Fully comply with UNDP’s GESI policy and ensure contribute to the zero tolerance for discrimination, harassment, sexual harassment, sexual exploitation, and abuse.
Perform other duties within your functional profile as assigned and deemed necessary for the efficient functioning of the office.
Job Specification
Required Skills and Experience
Education:
- Advanced university degree (Master’s Degree or equivalent) in Pharmacy, Pharmaceutical Sciences, or a related field is required. OR
- A first-level university degree (bachelor’s degree or equivalent) in the above-mentioned fields in combination with an additional 2 years of relevant experience will be given due consideration in lieu of master’s degree.
Experience:
- A minimum of 2 years (with a master’s degree) or 4 years (with a bachelor’s degree) of experience in pharmaceutical analysis, quality assurance, or regulatory affairs within national and international organizations or the public health sector.
- Excellent verbal and written communication abilities to effectively collaborate with team members, suppliers, and stakeholders.
- Experience in the use of computers and office software packages as well as web-based management systems is an asset.
- Familiarity with Nepal’s drug regulatory framework and global pharmaceutical standards.
- Strong knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Distribution Practices (GDP).
- Experience working in public health programs or donor-funded projects (e.g., Global Fund, USAID, WHO).
- Familiarity with procurement policies and procedures specific to the Global Fund or other donor-funded programs.
- Understanding of gender equality and diversity in Nepal’s context.
- Strong analytical skills to interpret data and make informed decisions.
Required Languages
- Fluency in English and Nepali is required.
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