ABOUT US

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; and 2) capacity-building activities to regulatory authorities to fulfill their function in ensuring the supply of quality-assured medical products.

PQM+ & COVID-19

United States Pharmacopeia was awarded The Promoting the Quality of Medicines Plus (PQM+) Program, a Cooperative Agreement between the United States Agency for International Development (USAID) and the United States Pharmacopeia (USP). PQM+ improves access to quality-assured priority medicines and addresses the proliferation of poor-quality medical products in low and middle-income countries through cross-sectoral and systems strengthening approaches and the application of international quality assurance standards across the pharmaceutical system. PQM+ is currently seeking a Pakistan-based consultant to contribute to the successful implementation of the PQM+ COVID-19 and other technical activities in Pakistan by providing coordination and support to the technical team.

ACTIVITY BACKGROUND

USP - PQM+ Pakistan team would like to hire a microbiologist consultant who will be expected to provide supervision of the selected laboratory microbiological section. The consultant will also be responsible for providing technical assistance for ISO 15189 accreditation to selected laboratories. Under the overall direction of PQM+ Chief of Party /Individual will:

• Conduct gap assessment of the quality management system of the microbiological section, biosafety level, biosafety manual, and ISO 15189 protocols at selected diagnostic labs.
• Prepare a gap assessment report of the microbiological section based on ISO 15189 standards, PPE Testing Labs, PPE Manufacturer and Pharmaceutical manufacturer specialty in area of media fill
• Assist the selected lab staff to prepare CAPA plans.
• Periodically monitor implementation of CAPA plans.
• Develop QMS documents for the microbiological section of selected diagnostic labs, PPE manufacturers, PPE testing Labs and Pharmaceutical manufacturers
• Support the ISO 15189 consultant to prepare the lab for ISO 15189 accreditation i.e. biosafety and biohazard manual.
• Assist and provides training to selected labs on internal audits and other required/ recommended practices and programs for microbiology sections.
• Train selected lab staff on biosafety and biosecurity.
• Provide technical assistance in developing monitoring strategies for laboratory performance.
• Assist in the development of phlebotomy training programs for blood cultures to improve sample throughput and reduce contamination rates.
• Assist and provide support in managing microbiological testing, sterile area monitoring, bioburden, BET (bacterial endotoxin test) of different medical devices, and their sterility testing along with environmental testing of the sterile area.
• Assist and support personnel/are validation for clean rooms
• Assist in laboratory management through providing training on using Biosafety Cabinets, Dry Heat Bath, Air Sampler, ETO Sterilizer, etc.
• Assisting in establishing and maintaining BSL1,2,3 and 4.

MANDATORY DELIVERABLES

• Gap assessment report
• Training reports
• CAPA plan
• List of QMS documents developed or reviewed.
• Biosafety and Biosecurity manuals,
• Required SOPS for Lab, PPE LABs, PPE Manufacturers and Pharmaceutical manufacturers

MINIMUM REQUIREMENTS:

• At least a master’s degree in microbiology along relevant training having significant microbiology component and relevant significant professional experience.
• At least five years’ experience working in a microbiological section or related fields.
• Demonstrated ability and aptitude to develop quality management systems and assessing the competence of laboratories conforming to international best practices of ISO 15189, 13485, 17025, 17020
• Having knowledge of PPE manufacturer standards, Media fill, clean room validation, environmental validation.
• Demonstrated creative problem-solving skills.
• Demonstrated success in engaging and working with multi-disciplinary teams and proven ability in training and mentoring technical staff.
• Excellent oral and written communication skills in English; knowledge of the local language is desired.
• Extensive practical laboratory experience and understandings of laboratory information systems.

PERIOD OF PERFORMANCE

The scope of the work defined herein should be implemented within the years 2020-2021 between the assignment will be for 12 months from the date of the sign of the contract.

GEOGRAPHIC AREA

Selected firm/ individual will develop and work remotely in consultation with the USP Pakistan team and travel Islamabad for delivering the scope of work. USP Pakistan may decide to change the locations (city with travel allowance). The consultant will be informed of such a change in advance.

REPORTING

Selected firm/ individual will report to the PQM+ Chief of Party and Deputy Chief of Party.

EVALUATION CRITERIA

• Financial Proposal - 35%
• Qualification and Education - 35%
• Past Experience - 30%