Sr. GMP Specialist, Pharmaceutical/Biotechnology

Company Name:
Technology Professionals
Our client organization is a scientific nonprofit entity that helps set standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. The standards they have developed are revised by more than 900 volunteer experts, including international participants, who work with them under strict conflict-of-interest rules. Since their founding in the nineteenth century, they have helped secure the quality of the American drug supply. Today they work with scientists, practitioners, and regulators of many nations to help protect public health worldwide.
An immediate need exists for a Sr. GMP Specialist for a hands-on, non-supervisory position where the incumbent understands the standards and principles of auditing manufacturing facilities for current good manufacturing practice (cGMP) compliance. The incumbent will analyze all elements of a quality system and judge its degree of compliance with the criteria of quality management, evaluation and control systems.
Required Skills
? Must have hands-on MANUFACTURING experience with injectables and parenteral pharmaceutical products.
? Must be able to travel internationally 35% of the time.
? Knowledge in CGMP drug development to commercialization.
? Knowledge of developing countries for both public health sector and generic pharmaceutical market including testing and manufacturing.
? Experience working for WHO prequalification program to assess dossiers and conduct GMP inspections and familiarity with WHO Common Technical Document (CTD) format for dossiers preferred.
? Excellent verbal, written and presentation skills; grant writing experience helpful.
? Ability to network with professionals from WHO, UNICEF, UNIDO, USFDA, EDQM, EMA, GDF, Global Fund and other donor foundations as well as local in-country representatives and government officials.
? Ability to work with virtual teams in remote locations.
? Ability to work with nationals from varied backgrounds and cultures.
? Language skills a plus (English, Spanish, French, Arabic or Mandarin).
Bachelors degree in Science

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