Crown Agents USA, Inc. (CA-USA) is seeking a Good Manufacturing Practices (GMP) Inspector for the Supply Chain Management Systems (SCMS) project in our Arlington, VA office.
Crown Agents is an international development company with offices in more than 30 countries, employing over 600 personnel worldwide. Crown Agents provides direct assistance, management consulting, and human and institutional development for public and private sector clients, particularly in customs and trade facilitation, public financial management, procurement, logistics, and health systems strengthening. Crown Agents currently operates in more than 85 countries on projects with an annual value of more than $181 million.
Crown Agents USA (CA-USA), the U.S. incorporated subsidiary of Crown Agents, provides direct technical assistance, capacity development, and procurement services to stimulate economic growth, establish good governance, and improve health outcomes across the developing world. Since its incorporation in the United States in 1998, CA-USA has provided technical assistance services and support to U.S. Government agencies and international organizations such as the U.S. Agency for International Development (USAID), the Millennium Challenge Corporation (MCC), the U.S. Trade and Development Agency (USTDA), and the Gates Foundation.
The Partnership for Supply Chain Management (PFSCM) is implementing the Supply Chain Management System (SCMS) contract for USAID as part of the President's Emergency Plan for AIDS Relief. SCMS strengthens or establishes secure, reliable, cost-effective, and sustainable supply chains capable of meeting the care and treatment needs of people living with and affected by HIV and AIDS. The Global Fund to Fight AIDS, Tuberculosis and Malaria is a major financing institution in the fight against these chronic diseases in 140 countries. The Global Fund established a Procurement Support Service to its Principal Recipients, with Voluntary Pooled Procurement (VPP) and Capacity Building Services aimed at ensuring a cost effective and efficient procurement process. These services will provide support to countries to resolve the procurement bottlenecks and supply chain management challenges and facilitate timely access to pharmaceuticals and health products.
Role & Responsibilities
The GMP (Good Manufacturing Practices) Inspector is a member of the QAU (Quality Assurance Unit) whose primary responsibility is to conduct GMP and/or GDP audits of PFSCM pharmaceutical manufacturers and wholesalers. Additional inspection support may be requested for manufacturers of diagnostic products and other medical devices.
- Schedule, prepare and conduct GMP/GDP audits per PFSCM QA policies
- Conduct audits in accordance with international recognized standards such as WHO or US FDA GMP
- Exercises judgment in determining manufacturer site approvals by evaluating quality systems and production controls for compliance to international best practices and ensuring that appropriate procedures are followed
- Communicate audit results through written audit reports to suppliers as well as provide updates to management and procurement as needed
- Manage post-audit activities and follow-up on necessary corrective and preventive action implementation
- BS/BA degree in Biology, Chemistry, Engineering, Microbiology or Pharmacy
- At least 5 years direct experience performing GMP audits in the Pharmaceutical manufacturing industry is required
- Excellent working knowledge of technical concepts for GMP auditing is required
- Knowledge of WHO and US FDA GMP requirements is required
- Knowledge of pharmaceutical regulatory requirements for international markets (US, EU, India, Africa) is required
- Excellent oral, written and interpersonal communication skills required
- Demonstrated ability to successfully manage conflict is required
- Demonstrated ability to interpret applicable standards and objectively make decisions is required
- Ability and willingness to travel internationally up to 50%
- Advanced skills in Microsoft Word, Excel and PowerPoint required
- Fluency in English is required; Proficiency in a secondary language is preferred
- Experience with inspections of sterile manufacturing sites is desirable
- Experience with inspections of manufacturers of rapid diagnostics and/or medical devices is desirable
- Experience working with international procurement organizations is desirable
- Experience working in resource poor countries a plus
- Must demonstrate personal attributes such as loyalty and integrity in addition to being determined and thorough, which is inherent in this position
To apply to this position, please email your CV to firstname.lastname@example.org . Include your name, along with the title of the position you are applying for, in the subject line. Visit our website at www.crownagentsusa.com for more information about our company. No phone calls, faxes or walk-ins please. Crown Agents USA, Inc. is an Equal Opportunity Employer M/F/D/V.
Candidate must be able to demonstrate legal right to work in the United States.
Crown Agents USA will provide reasonable accommodations to applicants with qualified disabilities in accordance with the ADA. If you require a reasonable accommodation for our application process, please contact our Recruiting department at ADArequests@crownagents.com . Requests will be kept confidential and shared strictly on a need-to-know basis only.
Crown Agents - 17 months ago