S/he must possess extensive knowledge in developing and implementing laboratory quality management systems, as defined in ISO/IEC 17025:2017 or WHO prequalification for pharmaceutical quality control laboratories, and practical experience in analysis of medicines quality. Under the guidance of the Panama’s program manager and in collaboration with technical advisors at USP headquarters in Rockville, MD, s/he will train and provide supportive supervision to IEA analysts, quality assurance manager, and management. This consultancy is a full-time position and has a period of performance from December 2022 through October 31, 2023.
Roles and Responsibilities
· Perform desk audit of laboratory quality system documentation
· Conduct onsite assessment of laboratory operations to include physical premises, equipment, supplies, procedures, data flows, and staff competencies
· Evaluate laboratory capacity to conduct microbiologic and physical-chemical testing of medicines
· Use root cause analysis to develop detailed implementation plans to address identified gaps, ensuring compliance with international standards for medicines quality control testing
· Provide technical assistance to address identified gaps in laboratory processes relative to international standards for medicines testing and WHO Global Benchmarking Tool (GBT) requirements
· Apply knowledge of analytical testing methodologies to develop training material and deliver hands on training for accurate analysis
· Apply knowledge of laboratory quality processes to develop training material and deliver training on several topics, such as root cause analysis, corrective actions, data integrity, among others
· Performs other duties as assigned by the supervisor
Basic Qualifications
· Deep domain knowledge and understanding of analytical concepts, principles, and theories related to chemical and microbiological analyses
Skills Sought
· Strong written (especially technical writing) and oral communication skills in both English and Spanish
· Hands-on experience in physical-chemical and microbiological testing of medicines
· Excellent training and facilitation skills. Experience training medicine laboratory testing regulators in low- and middle-income countries would be an advantage.
· Based in Panama or willingness to travel for extended periods to Panama
Preferred Qualifications
Period of Performance
The anticipated period of performance will begin in January 2022 and run through October 31, 2023.
Please send CV, 3-References, and Hourly Rate to ATTN: Masoud Azam, Senior Procurement Specialist, at GPH_Procurement@USP.org by the closing date of December 19, 2022, when submitting your application, write “Laboratory QMS and QC Consultant” 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 is an independent nonprofit organization with nearly 200 years of experience developing quality standards for medicines. Through its global public health programs, USP strengthens medicines quality assurance systems, increases the supply of quality-assured medicines, and develops capacity to detect and remove poor-quality medicines from the market. By sharing scientific expertise and providing technical support and leadership, USP helps local regulators improve and sustain local health systems and enables manufacturers to supply quality-assured essential medicines for years to come. Through these efforts, USP is able to help detect and identify poor quality health products in disease areas such as HIV/AIDS, tuberculosis, malaria and neglected tropical diseases, as well as helping safeguard the maternal, newborn, and child health sectors.
USP was awarded the Promoting the Quality of Medicines Plus (PQM+), a USAID-funded global program designed to sustainably strengthen medical product quality assurance systems in low-and-middle income countries. PQM+ is currently in its fourth year of implementation in Africa, Asia, and now in Latin America, and is seeking a bilingual (Spanish and English) consultant to provide technical assistance to Panama’s National Quality Control Laboratory (Instituto Especializado de Análisis [IEA]) to strengthen its capacity to provide reliable results for regulatory decision making by complying with international standards and norms for quality control testing of medicines and medical products. The consultant will assist IEA through information sharing of best practices, guided instructions on implementation techniques and methods, training on quality system processes as well as testing techniques, and other support for improving laboratory operations and meet the organization’s objectives.
