The U.S. Pharmacopeial Convention (USP) Technical Consultants in Rockville, Maryland
Global Public Health
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; 2) technical assessment to design and implement post market surveillance (PMS) activities to minimize substandard and falsified (SF) medicines in circulation, and 3 ) provide technical assessment to medicines national regulatory agencies (MNRA) to overall strengthen regulatory systems to fulfill their function in ensuring the supply of quality-assured medical products both through compliance and enforcement.
USP seeks consultants/vendors with expertise in one or more of the technical areas of interest below to be shortlisted for a candidate pool for potential future work in various countries throughout the Africa, Asia and Central Asia regions. This potential work would be completed under the guidance of USP’s Global Public Health (GPH) division. Applications may be made to one or more of the technical areas of interest, based on the consultant’s/vendor’s qualifications.
The Consultant(s) will assist and support GPH with program activities in strengthening regulatory systems for improving access to quality assured essential medicines and other medical products in low- and middle-income countries (LMICs).
TECHNICAL AREAS OF INTEREST
Knowledge of international guidelines and standards for therapeutics and diagnostics.
WHO pre-qualification and Bioequivalence (BE) study requirements;
Use of WHO global benchmarking tool (GBT) for assessment of regulatory systems;
Knowledge of accreditation programs (e.g., ISO 17025) and Quality Management Systems (ISO 9001);
ICH Guidelines (e.g., Clinical Trials, eCTD) and standards (e.g., MedDRA or medical dictionary for regulatory activities, and harmonized compendial standards).
World Health Organization Pre-Qualification (WHO-PQ) Assistance
Review and assessment of product dossier, BE studies;
Assist manufacturers to prepare product dossier for submission of WHO-PQ;
Provide training on critical aspects of product dossier to manufacturers, including organization of common technical document (CTD).
Bioequivalence (BE) study support
BE protocol review and interpretation of BE study data;
Review of Bioequivalence Trial Information Form (BITF);
Provide training on general aspects of Bioequivalence study;
Conduct audit of clinical research organizations (CROs) in good clinical practices (GCP) and good laboratory practices (GLP).
Post Market Surveillance (PMS) Assistance
Perform gap assessment of NMRA PMS activities;
Design and implementation of PMS protocols, resource allocation, and monitoring/evaluation of PMS activities;
Product Development and Technology Transfer Assistance
Provide support to manufacturers in scale-up and/or transferring process technology in compliance with cGMP;
Qualification of suppliers for raw materials and excipients;
WHO PQ assistance;
Provide support for any regional trade agreements, MOUs, cross-country registration.
National regulatory system: Laws/ Regulations, Policies, Governance in Low Middle Income Countries (LMNC)
Review and Identify the needs for laws, regulations and policies;
Conduct situation analysis to identify gaps and set policy objectives;
Bring together all interested parties to develop policies and promote ownership and set roles and responsibilities for all involved parties;
Establish strategies, plans, and procedures to effectively implement policies;
Establish and implement monitoring and evaluation (M&E) plan to monitor policy implementation.
Market authorization/ Product registration
Provide technical assistance to the regulatory agency to implement good regulatory practices, including processes for transparent and accountable review, product evaluation, and conformance assessment;
Strengthen the medical products registration system based on international best practices such as the common technical document (CTD) format;
Provide training in the key areas of assessment of the product dossiers in the common technical document format.
Integrated Regulatory information management systems (IRIMS)
Defining standards for the IRIMS;
Provide technical assistance in IRIMS conceptualization, data-base design and formatting, and tool management and technical requirements;
Program deployment of the standards developed in selected countries in LMICs in Asia and Africa.
Inspection: PIC/S certification
Provide technical assistance to adopt the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP standards and ascend to PIC/S membership;
Assist NMRAs to strengthen the regulations, QMS, and procedures for GMP inspection to meet PIC/S membership standards;
Assess MNRAs capacities and QMS and determine maturity level of inspectorates
on various Design support package to bring MNRAs to PIC/S level;
Training of inspectors’ components of GMP, GCP, GSDP and PV.
Current good manufacturing practices (cGMP) compliance auditor
cGXP, quality assurance (QA), and quality control (QC) compliance audit/assessment of Active Pharmaceuticals Ingredient (API), Finished Pharmaceutical Product (FPP), Vaccines and Biological/Biotechnological manufacturers as per current cGXP guidance’s (ICH Q7, 21CFR parts 210 and 211, WHO TR 957, 986 etc.);
Conducting risk assessment of potential cross-contamination issues;
Helping manufacturers in development and implementation of CAPA plan;
Providing cGXP training to staff of manufacturers for capacity building.
Process validation (Sterile and non-sterile);
Sterile filter including extractable and leachable;
Computer System Validation (CSV).
Good Engineering Practices (GEP) compliance;
Heating, Ventilation, and air conditioning (HVAC);
Equipment (API, FPP, Sterile etc.) qualification;
Utility (Water, Steam, Nitrogen and air etc.)
A minimum B.S degree in Physical, Chemical, Biological, Pharmaceutical Sciences or Engineering, in applicable professional areas;
A minimum of ≥ 5 years of relevant (cGXP, GCP, GLP) experience, preferably in the pharmaceutical industry under stringent regulatory authorities (i.e. US, EU, TGA etc.);
Familiarity with WHO-PQ Program and relevant guidance;
Experience working in low- and middle-income countries (Preferred);
Ability to travel internationally for up to 25% of the time (if applicable);
Excellent written and oral communication skills in English, including experience in training and mentoring staff and others.
APPLICATION SUBMISSION REQUIREMENTS
Please send a CV and list of references/contact information to GPH_consultancies@usp.org by 05/31/2020. Please clearly state the technical area(s) of expertise for which the consultant/vendor is applying in the subject line of the application e-mail.
Job Category Global Public Health