Technical Officer- Chemistry, Manufacturing, and Control (CMC)
Detailed Job description / requirements:
Position: Technical Officer- Chemistry, Manufacturing, and Control (CMC)
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.
The Promoting the Quality of Medicines Plus (PQM+) program, funded by USAID and implemented by USP, improves access to quality-assured priority medicines and addresses the proliferation of poor- quality medical products in low- and middle-income countries. PQM+ will strengthen medical product quality assurance systems 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, PQM+ helps create resilient and robust local health systems that address diseases like HIV/AIDS, tuberculosis, malaria and neglected tropical diseases, as well as improves maternal, newborn and child health.
USP is seeking for a Technical Officer- Chemistry, Manufacturing, and Control (CMC)in support of PQM+ program implementation in Nepal.
Summary of the Position
The Technical Officer for the Promoting the Quality of Medicines Plus (PQM+) Program is a non-supervisory position working as key member of chemistry, manufacturing, and control (CMC) team. S/he must possess a deep understanding of the pharmaceutical development process from pre-clinical development through life cycle management. The selected candidate will engage with the technical activities to support regulatory documentation system and facilitate technical assistance to pharmaceutical manufacturers in Nepal. As a team member of manufacturing activity, the technical officer supports the successful implementation of PQM+ objective of increasing supply of quality assured medicines. The technical Officer will assist in programmatic and resource planning for manufacturing activities
Roles and Responsibilities
- Supports for drafting and reviewing of technical documentation for inspection as per QMS requirements
- Applies knowledge of national and international best practices and guidelines in manufacturing practices to prepare the guideline documents on inspection, regulatory functions, and good manufacturing practices.
- Facilitates the development and implementation guidelines and regulations on manufacturing and control of medical devices and in vitro diagnostics in context of Nepal considering various national and international guidelines and best practices.
- Supports the works and efforts of the Technical Advisor to assist private and public industries to manufacture of quality assured essential medicines and medical products.
- Assists to organize and conduct training at regional and country level
- Implements the latest developments in information technology applied in manufacturing and regulations with respect to pandemic context.
- Deploys the new trends and technologies to Nepali manufacturers to enhance the production of quality assured medicines.
- Represents organization in pharmaceutical manufacturing fraternity in country
- Supports for capacity building and development in manufacturing and regulations with respect to latest pharmaceutical technology
- Work closely with country office team to support development and deployment of strategies in pharmaceutical development
- Supports on reporting, documentation, and resource planning to develop periodic reports.
- Coordinates with country office team to ensure a high level of quality combined with overall value to USP.
- Bachelor’s degree in Pharmacy, pharmaceutical science, chemistry, engineering, or science related field of study required
- Minimum of 6 + years of experience in pharmaceutical manufacturing
- Understanding of national and international (WHO, ICH, PIC/S,) guidelines on good manufacturing practices
- Understanding of regulatory inspection process, legal provisions, regulations, and guidelines
- Strong written (especially technical writing) and oral communication skills
- Willingness to travel at least 25% of the time.
- Master’s Degree in Pharmacy, pharmaceutical science, chemistry, engineering or science related field of study required
- Understanding of WHO prequalification of medical products
- Understanding of WHO global benchmarking tool
- Experience at least one of the following health areas: MNHC, FP, HIV/ AIDS, malaria, TB, NTDs,
- Non-supervisory position
Interested candidates should submit cover letter and CV by email to GPHNepalRecruitment@USP.org clearly stating Technical Officer- Chemistry, Manufacturing, and Control (CMC) in the subject line of the e-mail.
Application Deadline: September 27, 2021