International PIC/s Consultant

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.

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.

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

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

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

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.