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 laboratory Associate Engineer who will be qualified to provide technical services to Central Drugs Testing Laboratory (CDL), Karachi. Under the overall direction of PQM+ Chief of Party individual will:

1.        Assist in execute laboratory testing according to standard procedures, making observations, and interpret findings to produce precise and reliable data recording.

2.       Organize and store all, equipment’s, materials, chemical substances, fluids, and compressed gases according to safety instructions.

3.       Establish and ensure that an acceptable General Laboratory Policy and Procedure inclusive of a Quality Control Program and a Quality Assessment Plan is in place and is followed according to guidelines for acceptable performance.

4.        Assist in Selection, verify, establish, and monitor the acceptable level of the analytical performance of test methods as appropriate to technical heads.

5.       Assist in Support the labs in maintaining quality results by running standards and controls, verifying equipment function through routine equipment maintenance and advanced troubleshooting, calibrating equipment utilizing approved testing procedures, monitoring quality control measures, and protocols. 

6.       Assist to Ensures maintenance of equipment by evaluating its safety, efficiency, and effectiveness.

7.       Assist to Stores chemicals properly, disposes of chemical waste, adheres to safety procedures, and participates in safety programs.

8.       Assist to Manages inventory (track and document chemical usage), maintains processes, and orders laboratory supplies, including glassware and chemicals for biotech/pharmaceutical processes.

9.       Assist to Maintaining, calibrating, regulating, cleaning, and testing sterility of the electronic as well as mechanical equipment

10.   Assist in the development of SOPs and internal audits.

11.   Assist in Provides technical support and updates the logbooks.

12.   Assist technical support for collecting, preparing, and/or testing samples and for recording and analyzing data.

MANDATORY DELIVERABLES

1.       Weekly and Monthly activity report.

2.       List of relevant studied documents developed/reviewed.

3.       Attend all training on lab technics, QMS, preventive maintenance of equipment’s, equipment operation.

4.       Logbooks.

MINIMUM REQUIREMENTS:

1.       At least a bachelor’s degree in lab Biomedical technology or medical or Bachelor any other related field with three years’ experience as biomedical technician in a hospital setting or a quality control lab or a relevant position.

2.       Or DAE (Diploma in Electronics, Biomedical) with 7 years’ experience

3.       Demonstrated ability and aptitude to select, verify, establish, and monitor the acceptable level of the analytical performance of various test methods.

4.       Possess critical thinking for identifying the strengths and weaknesses of the facility.

5.       Demonstrated experience in operations monitoring of electrical and nonelectrical laboratory equipment and potentially dangerous substances (flammable liquids, biohazards, etc.)

6.       Excellent oral and written communication skills in English; knowledge of the local language is desired.

7.       Extensive experience as a laboratory supervisor, manager, or technical consultant.

PERIOD OF PERFORMANCE

The scope of the work defined herein should be implemented within the years 2020-2021 between the assignment will be for 11 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), increase or decrease the number of deliverables. 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

1.       Financial Proposal - 50%

2.       Qualification and Education - 25%

3.       Past Experience - 25%