ABOUT US

 The U.S. Pharmacopeial Convention (USP) is a scientific non-profit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. Our mission is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP envisions a world in which all have access to high quality, safe, and beneficial medicines, and foods. USP approaches this vision with a sense of urgency and purpose, strengthened by its cadre of dedicated volunteers, members, and staff, and by working collaboratively with key stakeholders across the globe. As the world gets smaller and more connected, quality issues affect everyone. Diseases travel. Drug resistance grows. Fake medicines kill. The foundation of quality we are building helps address these and other global health issues. Whether decreasing the prevalence of substandard and poor-quality medicines or helping to curb antimicrobial resistance, we are there working to protect the health of people all over the world.

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.

ACTIVITY BACKGROUND

 

USP - PQM+ Pakistan team would like to hire a International Consultant/Organization who will provide regulatory directions to DRAP for strengthening of regulatory system, strategy and organize roadmap to attain Pharmaceutical Inspection Cooperation Scheme (PIC/s) membership/ accreditation/recognition. The consultant would provide direction in the following areas.

 

1. Desk review of documents provided by DRAP and GAP Assessment of DRAP’s system and processes for PIC/s compliance
2. Support DRAP for CAPA preparations as per gap assessment report
3. Provide Virtual Training for DRAP Staff on PIC/s Standards and guidelines
4. Provide Virtual Training of DRAP Staff for inspections of Industries
5. Assessment of CAPA implementation against gap assessment
6. Support DRAP to submit application for PIC/s Membership

MANDATORY DELIVERABLES

1. GAP Assessment Report of DRAP
2. CAPA Plan implementation assessment
3. Trainings Material

MINIMUM REQUIREMENTS 

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

 

PERIOD OF PERFORMANCE 

The scope of the work defined herein should be implemented within the years 2021-2022 between, the assignment will be for 15 working days 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 DRAP team.

 

REPORTING

 

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

 

EVALUATION CRITERIA

1. Past Experience - 40% 
2. Qualification and Education - 35% 
3. Financial Proposal- 25% 

INSTRUCTIONS:                                                                                                                                           

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

IMPORTANT NOTE 

Please send CV/Profile, 3-References, and Daily Rate by downloading the following ANNEX – D (Template):

https://drive.google.com/file/d/1SNQftPHB25vpRZTcznnsDrFRB8d2r7d1/view?usp=sharing

The Quoted Per Day Rate (USD) should be inclusive of all applicable taxes.

 

Kindly send all Technical and Financial Proposals to ATTN:  USP Pakistan Procurement at [email protected] before the closing date (December, 9^th 2021). When submitting your application, write "International PICS Consultant" in the email Subject Line.