Technical Officer - Quality Assurance and Quality Control (QA/QC)

Position: Technical Officer - Quality Assurance and Quality Control (QA/QC)

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 Technical Officer - Quality Assurance and Quality Control (QA/QC) in support of PQM+ program implementation in Nepal.

Summary of the Position

This is a non-supervisory, individual contributing position responsible for the on-site day-to-day activities at National Medicines Laboratory. S/He will work with the Technical Advisor-QA/QC and NML to achieve the goals of the laboratory workplan of PQM+ Nepal. The technical officer will be directly involved in lab to strengthen their quality system and good laboratory practices to meet the objective of NML accreditation with ISO 17025:2017 standards.

Roles and Responsibilities

• Assist in technical QA/QC implementation of PQM+ by helping in technical trainings in laboratory quality management systems, instrumental techniques and good documentation practices
• Coordinate with Quality Manager NML and Technical Advisor QA/QC to map the process for the various technical and management activities.
• Support lab to prepare various technical and management documents i.e., Quality Manual, Standard Operating Procedures, Working Instructions, Information Management Forms and Formats and Master lists of documents and equipment.
• Facilitate PQM+ activities at NML, like improving NML’s inventory management system, data management system, laboratory safety, warehousing of chemicals, reference standards and samples, and so on.
• Support the Technical Advisor QA/QC to give updates on the laboratory activities in monthly/ quarterly/ annual reports; and to prepare the annual work plan.
• Assist the technical advisor QA/QC to prepare NML for ISO 17025 accreditation by supporting in Mock Audits, Internal Assessments, CAPA plans, and preparation of laboratory information files to be submitted to accreditation body.

Basic Qualifications

• B. Pharm or equivalent.
• Minimum of five (5) years of experience in the Pharmaceutical Quality Control Laboratory.
• Minimum of two (2) years of experience in the Quality Management of laboratory.

Preferred Qualifications

• M. Pharm or equivalent.
• Prior experience in USAID project
• Prior experience in ISO 17025 accreditation.
• Good knowledge of Microsoft Word and Excel operations.,

Application Process:

Interested candidates should submit cover letter and CV by email to GPHNepalRecruitment@USP.org clearly stating Technical Officer - Quality Assurance and Quality Control (QA/QC)in the subject line of the e-mail.

Application Deadline: September 27, 2021