Vacancy Announcement for Technical Officer PMS US Pharmacopiea Nepal

Description

Summary of the Position

The Technical Specialist 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 specialist supports the successful implementation of PQM+ objective of increasing supply of quality assured medicines. The technical specialist will assist in programmatic and resource planning for manufacturing activities. .

Roles and Responsibilities

1. Planning, Coordination and Management:
2. Coordinate with the officials of Planning, Coordination and Management Division of DDA and Technical Advisor QA/QC to facilitate various processes regarding PMS activities as per work plan.
3. Facilitate PQM+ activities at DDA and NML. For example: assisting the technical advisor in field visits for RB-PMS activities, drafting reports, coordinating with officials, preparing meeting minutes, drafting required documents etc.
4. Document Review, Designing and Endorsement:
5. Support the planning, coordination, and management division to draft/ revise various technical and management documents for RB-PMS, like Standard Operating Procedures, Information management Forms and formats, RB-PMS reports etc.
6. Assist to organize and facilitate trainings, meetings (like documentation, communication and so on)
7. Capacity Building, Data Management and Reporting
8. Assist in technical QA/QC implementation of PQM+ by helping in preparation and management of trainings at the PMS section of DDA.
9. Program Support:

• Help the Technical Advisor QA/QC to give updates on the PMS activities in monthly/ quarterly/ annual reports; and to prepare the annual work plan.
• Assist Technical Advisor QAQC on program related activities, when and where required.

Basic Qualifications

• Masters of Pharmacy
• Minimum of five (5) years of experience in the Pharmaceutical Quality Assurance.
• Experience in working with medicine regulatory authority in Nepal.
• Experience in community/hospital pharmacy or in supply-chain of pharmaceuticals.

Preferred Qualifications

• Pharm or equivalent.
• Prior experience in USAID project
• Prior experience in post-marketing surveillance.
• Good knowledge of Microsoft Word and Excel operations

Supervisory Responsibilities

• None

Benefits

USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.

About USP

The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world’s top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Job Category Technical Programs

Job Type Full-Time