Short Term Consultant

Job Description

Scope of Work

Short Term Consultant – Laboratory Quality Document Development

Duty Station: Kathmandu, Nepal

Collaborating Authorities: NML: Quality Manager & Acting DG; PQM+: Technical Advisor QA/QC

Period of Performance: Apr – Aug 2021 (Total LOEs: 60 Days)

Overview

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.

The Promoting the Quality of Medicines Plus (PQM+) program, funded by USAID and implemented by USP, improves access to quality-assured priority medicines and addresses the proliferation of poor- quality medical products in low- and middle-income countries. PQM+ will strengthen medical product quality assurance systems through cross-sectoral and systems strengthening approaches and the application of international quality assurance standards across the pharmaceutical system. By sharing scientific expertise and providing technical support and leadership, PQM+ helps create resilient and robust local health systems that address diseases like HIV/AIDS, tuberculosis, malaria and neglected tropical diseases, as well as improves maternal, newborn and child health.

USP is seeking for a Short-Term Consultant – Laboratory Quality Document Development, to support PQM+ program implementation in Nepal.

The consultant will be responsible for development of documents and other day-to day activities of PQM+ at NML. S/he will work closely and dedicatedly with NML officials to prepare various documents required to fulfill the accreditation requirements of ISO 17025. Additionally, the short-term consultant will facilitate tasks mentioned in the development plan formed after the first Gap assessment, that NML is not able to do due to lack of human resource. The goal of short-term consultant will be strengthening NML to fulfill the gaps to-comply accrediting standards.

Roles and responsibilities

• Coordinate with Quality Manager NML and Technical Advisor QA-QC to map the process for the various technical and management activities.
• Prepare various technical and management documents i.e., Quality Manual, Standard Operating Procedures (approx. 30), Working Instructions, Information Management Forms and Formats and Master lists of document and equipment.

Deliverables and Level of Effort:

• Quality Manual (15 days)
• Standard Operating Procedures – (20 days)
• Working Instructions (10 days)
• Information management Forms and Formats (10 days)
• Master lists (5 days)
  • Documents
  • Equipment
• Final report

Required Qualification & Experience

Qualification:

• Minimum Bachelor’s degree in pharmacy, pharmaceutical science, chemistry, microbiology, or biotechnology.
• Minimum 5 years of experience in quality assurance and preferably worked inQC Laboratory.
• Experienced in developing laboratory documents and standard operating procedures.
• Hand-on knowledge of WHO Pre-Qualification and ISO 17025 Accreditation.
• Experience and understanding of CAPA, document control, record control, good documentation practices, internal auditing, and quality management system structure.

How to Apply

Application Process:

Eligible consultant/s may submit an Expression of Interest based on the above basic requirements including their consultancy fees per day basis, CV, sample of previous work, and copy of PAN/VAT registration certificate. Application should be indicated in the subject “Short Term Consultant – Laboratory Quality Document Development” ” and submit to usp.nepal@usp.org by 5 April  2021 (5:00 PM).