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.
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.
- Support DRAP for CAPA preparations and its implementation as per the gap assessment report
- Review the Quality Management System of the DRAP Inspectorate
- Review Risk Based inspection system and risk categorization criteria of DRAP for the Industry
- Finalization of CAPA Plan on gap assessment observation of DRAP
- Review implementation of planned CAPA
- Review QMS of DRAP Inspectorate and sample inspection reports
- 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).
The individual will work with the USP Pakistan team based at Islamabad Office. (Full-Time/Hybrid Mode).
- Previous Experience – 40%
- Qualification and Education – 40%
- Financial Proposal- 20%
The applicant is required to have the aforementioned professional and technical qualifications. Only the applicants who hold these qualifications will be shortlisted and contacted.
- Job Type : Contract
- Industry : NGO & Non Profit
- Educational Specialization : Others
- Role / Designation : International PIC/s Consultant
- Last Date to Apply : 12/01/2023
- Salary : Your starting salary is negotiable depending on your skills and experience.
- Requirements : PIC GMP Audit International Regulatory Association Pharmaceutical Policy Command Pharmaceutical Inspection Cooperation Pharmaceutical Regulatory System
- Apply Online