International PIC/s Consultant

ABOUT US

The U.S. Pharmacopeial Convention (USP) is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. We are working to strengthen the global supply chain so that the medicines people rely on for health are available when needed and work as expected. USP’s Global Health programs work with donors and partners in low- and middle-income countries to advance access to quality-assured essential medical products and strengthen supply chains to address critical global health threats such as COVID-19, tuberculosis, HIV and AIDS, and maternal and child health conditions.

PQM+

The Promoting the Quality of Medicines Plus (PQM+) program is a five-year U.S. Agency for International Development (USAID)-funded cooperative agreement with a goal to sustainably strengthen medical product quality assurance systems in low- and middle-income countries (LMICs). PQM+ provides technical assistance to Medicines Regulatory Authorities in a number of countries in Asia. This cooperative relationship supports the Drug Regulatory Authority of Pakistan (DRAP) for regulatory reforms, quality assurance systems, and strengthening the quality control laboratories in Pakistan. Moreover, PQM+ also provides technical capacity building in close coordination with DRAP and provincial health authorities.

ROLE OVERVIEW

USP seeks the services of an international PIC/s Consultant to assist and guide DRAP in preparation for PIC/s and application submission. The consultant will train DRAP staff on PIC/s guidelines and procedures and guide DRAP on structural modifications where required. The Consultant(s) will be called to work on an as-needed basis, under specific Work Orders, and will report to the Consultant Supervisor listed on the Work Order. USP - PQM+ Pakistan team would like to hire a regulatory consultant who will work to provide regulatory system-strengthening support to manufacturers/stakeholders. Under the overall direction of the PQM+ Chief of Party the Individual will:

KEY RESPONSIBILITIES

1. Support DRAP for CAPA preparations and its implementation as per the gap assessment report
2. Review the Quality Management System of the DRAP Inspectorate
3. Review Risk Based inspection system and risk categorization criteria of DRAP for the Industry
4. Review 03 inspection report of risk-based inspections
5. Provide Virtual Training for DRAP Staff on PIC/s Standards and guidelines
6. Provide Virtual Training of DRAP Inspectorate for inspections of Industries
7. Assessment of CAPA implementation against gap assessment
8. Support DRAP to submit an application for PIC/s Membership

DELIVERABLES

1. Finalization of CAPA Plan on gap assessment observation of DRAP
2. Review implementation of planned CAPA
3. Review QMS of DRAP Inspectorate and sample inspection reports
4. Training of DRAP staff on PIC/s Guidelines and Procedures
5. Training of DRAP inspectors on PIC/s inspection criteria for industries
6. Preparation and submission of DRAP application to PIC/s.

MODE

Submission of Report and Invoice for the Programmatic Deliverables

ESTIMATED DUE DATE

September 30th 2023

QUALIFICATIONS

• At least a master’s degree in Pharmaceutical Sciences.
• At least Fifteen years of experience in the Pharmaceutical Regulatory System
• Internationally Proven 5 years experience with PIC/s Member Regulatory Authorities.
• Hands-on experience and work understanding of the implementation of PIC/s Standards
• Should have hand on experience with at least 05  countries for PIC/s Membership
• Demonstrated ability in developing policies, regulations, and guidelines according to PIC/s Standards
• Demonstrated ability to lead professionals and manage others through influence and collaboration.
• Demonstrated ability to conduct and interpret quantitative/qualitative information with analytical problem-solving.
• Proven leadership skills in consulting with demonstrated experience in training and mentoring staff and others.
• Excellent oral and written communication skills in English; knowledge of the local language is desired.
• Must demonstrate an understanding of the operations, health policy trends, and any applicable regulations related to the responsible technical area.

PERIOD OF PERFORMANCE

The anticipated period of performance will be March 1st, 2023 to September 30th, 2023. The Anticipated Contract Type is a Master Agreement and Work Orders will issue under MCA. The assignment will be required a maximum of 15 Working Days Level of Effort (LOE).

GEOGRAPHIC AREA

The individual will work with the USP Pakistan team based at Islamabad Office. (Full-Time/Hybrid Mode).

EVALUATION CRITERIA

• Previous Experience - 40%
• Qualification and Education - 40%
• Financial Proposal- 20%

INSTRUCTIONS

The applicant is required to have the aforementioned professional and technical qualifications. Only the applicants who hold these qualifications will be shortlisted and contacted.