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+

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) is a five year (2019 - 2024), PQM+ improves access to quality-assured πpriority 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. By sharing scientific expertise and providing technical support and leadership, we help create resilient and robust local health systems that address diseases like HIV/AIDS, tuberculosis, malaria, and neglected tropical diseases, as well as improve maternal, newborn, and child health.

ACTIVITY BACKGROUND

USP - PQM+ Pakistan team would like to hire a regulatory consultant who will work to provide regulatory system strengthening support to manufacturers. Under the overall direction of PQM+ Chief of Party the Individual will:

1.       Provide technical assistance in terms of adhering to regulatory affairs in manufacturing sector in  Pakistan that will enhance the ability of USP PQM+ to conduct its technical assistance work to improve the medicine quality assurance program in Pakistan, with specific work requested by program partners and approved by PQM+ COP.

2.       Works hand-in-hand with the COP and team, to provide technical advice to selected manufacturers, particularly in good Regulatory Practice , medicines regulation, development/review of  Pharmaceutical quality management system at manufacturer level, Dossier development for WHO PQ, PICs Countries and other regulatory authorities including DRAP on CTD/ eCTD or any other format as required.

3.       Provides technical assistance to potential manufacturers on therapeutic product Common Technical Document (CTD) dossier development and generation of DATA, documentation, following data integrity and any related regulatory requirements.

4.       Provide Regulatory assistance to manufacturer on all regulatory aspects.

5.       Manages specific PQM+ project activities as assigned by the PQM+ Chief of Party or Deputy Chief of Party and/or the PQM+ HQ Rockville.

6.       Ensures that all project work for the PQM+ office is completed by country partners on time, on target, and budget.

7.       Actively take part in preparing activity reports to USP-PQM+, USAID Pakistan, and other country partners within the set parameters of the contract.

8.       Prepare presentations, training materials, and organize training programs in specialist skills areas.

9.       Provides support to manufacturers for preparing the common technical document (CTD) dossier for permanent registration with DRAP.

10.   Assist in the development and implementation of the CAPA plan.

11.   Assist manufacturers to formulate and compile dossiers for export.

12.   Organize a consultative meeting to develop risk-based post-marketing surveillance (RB-PMS) plan for products including COVID-19 based on the existing RB-PMS framework with DRAP, provinces & regions.

MANDATORY DELIVERABLES

1.       Training materials

2.       Training reports

3.       Complete Pharmaceutical quality management system

4.       Prepared for WHO PQ/ Any regulatory inspection and assist manufacturer before and during inspection.

5.       Dossiers submitted for permanent registration in Pakistan, in other countries & for WHO PQ.

6.       Minutes of consultative meetings.

7.       Risk-based PMS plan for COVID-19 products

MINIMUM REQUIREMENTS:

1.       At least a bachelor’s degree or other professional degrees in pharmaceutical sciences.

2.       At least five years’ experience in pharmaceutical quality assurance and/or regulatory affairs

3.       Having experience dealing with regulations WHO PQ/ PICs counties approval of products. Having good knowledge of medicine regulations for WHO PQ, PICs, US FDA, EMEA and ICH countries

4.       Having good knowledge of latest international Guideline in Pharmaceutical field by ICH countries.

5.       Demonstrated creative problem-solving skills to come up with procedures and policies to deal with issues related to regulatory compliance.

6.       Demonstrated experience in training and mentoring staff and others.

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

8.       Good interpersonal skills and teamwork skills with the ability to lead and engage with other project team members and to develop clear policies.

9.       Working within a quality-focused environment with the ability to deliver against agreed timelines whilst managing workloads and resources to ensure targets are met.

10.   They also need to have teamwork skills because their work can involve collaborating with other departments.

11.   Analytical skills are needed to review existing procedures, and they also need to have time management skills to meet deadlines and file paperwork on schedule.

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), 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.

EVALUATION CRITERIA

1.       Financial Proposal - 35%

2.       Qualification and Education - 35%

3.       Past Experience - 30%