U.S. Pharmacopeial Convention Jobs

Job Information

The U.S. Pharmacopeial Convention (USP) Technical Advisor PQMPlus in Islamabad, Pakistan

Description

The Technical Advisor, Good Manufacturing Practices (GMP) will have expert skills in pharmaceutical manufacturing and authoring the GMP sections of regulatory submissions. He/she must possess a deep understanding of the pharmaceutical development process from pre-clinical development through life cycle management. The selected candidate will engage with and leads all technical support provided to pharmaceutical manufacturers in Pakistan. As the lead for PQM+ pharmaceutical manufacturing activities in Pakistan, the Technical Advisor provides technical oversight related to the program’s objective of increasing the supply of quality-assured, essential medical products, including provision of technical assistance to manufacturers (including, Product development, GMP, PQMS, regulatory/dossier development and submissions). Additionally, he/she acts is a recognized leader, interfacing with the Pakistan Pharmaceutical Manufacturers’ Association, manufacturers, Pharma Bureau, the Drug Regulatory Authority of Pakistan (DRAP), provincial & regional drug control departments, inspections unit and stakeholders involved in supplying and manufacturing essential medicines.

Roles and Responsibilities

• Provides technical oversight of activities to support local manufacturers in Pakistan

• Leads in the delivery of trainings at regional and country level

• Provide oversight for local GMP staff, local partners and consultants involved in delivery of manufacturing support

• Work closely with country teams to support development and deployment of strategies in pharmaceutical sector development

• Supports the work and efforts of the Technical Director and the center of excellence to develop technical documents on the manufacturing of quality generic medical products

• Keep abreast of the latest guidelines, analytical technology in industry and regulation requirements

• Technical POC at regional and country level with organizations such as the Pakistan Pharmaceutical Manufacturers’ Association and Pharma Bureau

• Recognized leader in the Pakistan pharmaceutical sector actively advancing and deploying new technologies and trends in pharmaceutical manufacturing

• Represents the organization in local and regional forums on manufacturing

• Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports

Basic Qualifications

• Bachelor’s degree in pharmacy, pharmaceutical science, chemistry, engineering or science-related field of study required

• Minimum of 10 + years of experience in pharmaceutical manufacturing, Quality Management System, regulatory submissions, and good review practices.

Skills Sought

• Direct experience with and understanding of WHO pre-qualification process

• Subject matter expert in any of the manufacture of generic medical products.

• Working understanding of Good Manufacturing Practices/Chemistry, Manufacturing and Controls

• Strong written (especially technical writing) and oral communication skills

• Willingness to travel at least 25% of the time.

Preferred Qualifications

• Direct experience implementing USAID-funded programs

• Minimum of 5+ years people management experience and skills

• Experience at least one of the following health areas: HIV/ AIDS, malaria, TB, NTDs, AMR, MNCH

Supervisory Responsibilities

None at this time.

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

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