International Good Manufacturing Pharmaceutical practices (GMP)
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Location:
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Salary:negotiable / YEAR
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Job type:CONTRACTOR
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Posted:2 months ago
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Category:
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Deadline:22/08/2024
JOB DESCRIPTION
ABOUT THE COMPANY:
The United Nations Industrial Development Organization (UNIDO) is the specialized agency of the United Nations that promotes industrial development for poverty reduction, inclusive globalization and environmental sustainability. The mission of UNIDO, as described in the Lima Declaration adopted at the fifteenth session of the UNIDO General Conference in 2013, is to promote and accelerate inclusive and sustainable industrial development (ISID) in Member States. The relevance of ISID as an integrated approach to all three pillars of sustainable development is recognized by the 2030 Agenda for Sustainable Development and the related Sustainable Development Goals (SDGs), which will frame United Nations and country efforts towards sustainable development in the next fifteen years.
UNIDO’s mandate is fully recognized in SDG-9, which calls to “Build resilient infrastructure, promote inclusive and sustainable industrialization and foster innovation”. The relevance of ISID, however, applies in greater or lesser extent to all SDGs. Accordingly, the Organization’s programmatic focus is structured in four strategic priorities: Creating shared prosperity; Advancing economic competitiveness; Safeguarding the environment; and Strengthening knowledge and institutions.
JOB SUMMARY
Under the overall direction of the Director General, and in close collaboration with all relevant organizational entities within UNIDO, the Directorate of Technical Cooperation and Sustainable Industrial Development (TCS), headed by a Managing Director, ensures the Organization’s application of strategies and interventions for sustainable industrial development related to environment, energy, Micro, Small and Medium-Enterprises (MSMEs), and digitalization.
The Directorate also oversees the Organization’s normative contribution to achieving the Sustainable Development Goals through industrial policy advice and capacity development.
Through coordination in-house and with Member States and industry stakeholders, it ensures that the services provided in these areas contribute to effective and appropriate technical, business and policy solutions and are focused on results, scaling up and positioning UNIDO as a leading platform for industrial development in developing countries and global fora.
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Requirements
Education: Advanced degree in Pharmaceutical Sciences, Engineering, or a related field.
Proven experience in pharmaceutical manufacturing and regulatory environments.
The expert must be Six Sigma certified and proficient in lean manufacturing, Six Sigma, Kaizen, and circular economy principles, specifically applied to the health industry.
Experience, technical and functional expertise
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- A minimum of 7 years of professional experience, including some at the international level, in managing GMP implementation processes and conducting GMP compliance assessments in the pharmaceutical sector is required.
- The expert must be Six Sigma certified and proficient in lean manufacturing, Six Sigma, Kaizen, and circular economy principles, specifically applied to pharmaceutical manufacturing.
- Experience working with various stakeholders in the pharmaceutical industry, including companies, government agencies, and international organizations, with knowledge of their operational models, market dynamics, and regulatory environments, is required.
- Demonstrated experience in GMP compliance, regulatory frameworks and the best practices within the pharmaceutical sector
- Experience working in or with developing countries, particularly in Africa, is highly desirable.
- Demonstrated ability to author publications and research reports on GMP, pharmaceutical manufacturing, and regulatory compliance, with experience in preparing strategic documents for international organizations, companies, and government agencies, is required.
- Demonstrated ability to conduct trainings and workshops for participants from private sector companies, focusing on best practices in pharmaceutical manufacturing and regulatory compliance while providing comprehensive training materials is required.
Languages: Fluency in written and spoken English and French is required.
Responsibilities
Under the close supervision of the Project Manager and the project team, the International Expert shall fulfil the following duties:
- Guideline and Strategy Development: Develop a comprehensive guideline and strategy, including a step-by-step assessment tool for evaluating and integrating best practices in pharmaceutical manufacturing.
- HOW TO OPERATIONALIZE GMP ROADMAP – Assess Pharma companies’ compliance to GMP and support their access to leveraged experience and implementing the GMP practices in their facilities.
- Focus Areas: Concentrate on regulatory compliance and laboratory practices, emphasizing identifying opportunities for diversification in the pharmaceutical sector.
- Assessment Focus Areas: Assess 4 key areas:
- Organizational: HR, skills development, and workforce optimization.
- Regulatory: Compliance, regulatory frameworks, and quality assurance.
- Production: Efficiency, innovation in production processes, and lean manufacturing practices.
- Opportunities: Product diversification, market access, and investment opportunities.
- Integration Guide: Develop a detailed, step-by-step guide for assessing and integrating improvements in the identified focus areas.
- Training and Workshops: Conduct trainings and workshops for participants from private sector companies in Senegal.
- Stakeholder Engagement: Actively participate in discussions and engage with public and private sector stakeholders in Senegal.
REQUIRED EDUCATION: Postgraduate Degree
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EXPERIENCE REQUIREMENTS: 84
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