Consultant for Good Manufacturing Practices (GMP) Inspection System

Job Posting Organization:
The Afghanistan Food and Drug Authority (AFDA) serves as the national regulatory authority responsible for ensuring the quality, safety, and efficacy of medicines, medical devices, healthcare products, and food in Afghanistan. Established to address the pressing need for a robust regulatory framework, AFDA plays a crucial role in protecting public health and ensuring compliance with international standards. The organization is focused on overcoming challenges such as limited technical capacity and inconsistent adherence to quality standards, which are critical for the development of a resilient health system in Afghanistan. AFDA operates within a complex environment where it must navigate the intricacies of product registration, inspections, licensing, and market surveillance, all while striving to enhance the overall quality assurance systems in the country. The organization is committed to aligning its regulatory functions with WHO norms and standards, thereby contributing to the broader goals of health system resilience and universal health coverage in Afghanistan.

Job Overview:
The consultancy aims to strengthen Afghanistan's Good Manufacturing Practices (GMP) inspection system by enhancing the technical capacity of the Afghanistan Food and Drug Authority (AFDA) inspectors. The consultant will conduct joint GMP assessments of selected local manufacturers, identify compliance gaps, and support AFDA in reviewing corrective and preventive action (CAPA) plans. This role is pivotal in improving the quality of inspections and compliance among local manufacturers, which is essential for the safety and efficacy of healthcare products in Afghanistan. The consultant will also contribute to the implementation of Institutional Development Plans (IDPs) under the WHO Global Benchmarking Tool (GBT) related to GMP inspections. The position requires a dual approach that includes strengthening inspection capacity within AFDA and providing practical, hands-on technical support to manufacturers, thereby ensuring that inspection findings lead to effective and sustainable corrective actions.

Duties and Responsibilities:
The consultant will be responsible for several key deliverables, including:

• Conducting training materials and a report for hands-on GMP assessment training of regulatory staff and inspectors, along with a progress report on the implementation of WHO GBT IDPs related to GMP inspections.
• Providing GMP assessment reports for selected local manufacturing facilities, which will include gap analyses and recommendations for improvement.
• Developing CAPA support reports that detail corrective actions, follow-up guidance, and a comprehensive roadmap for achieving GMP compliance. The consultant will work under the supervision of the Technical Officer and Team Manager, ensuring that all activities align with the strategic goals of AFDA and WHO.

Required Qualifications:
Essential qualifications include a university degree in Pharmacy, with a desirable specialization or Master’s degree in quality assurance or pharmacy. The consultant must possess excellent interpersonal and communication skills, a high sense of responsibility, and strong organizational skills, with the ability to work effectively under pressure. Advanced computer literacy in applications such as Word, Excel, and PowerPoint is also required. The consultant should demonstrate a commitment to ethical standards and professional integrity, aligning with WHO's values.

Educational Background:
Candidates must hold a university degree in Pharmacy as a minimum requirement. A specialization or Master’s degree in quality assurance or pharmacy is highly desirable and will enhance the candidate's suitability for the role. Educational qualifications must be obtained from institutions accredited or recognized in the World Higher Education Database (WHED).

Experience:
The position requires 5 to 10 years of relevant experience in GMP inspection, with international experience being mandatory. Candidates should have a proven track record of working in regulatory environments and possess a deep understanding of GMP standards and practices. Experience in conducting training and assessments in a regulatory context will be advantageous.

Languages:
Excellent knowledge of English is mandatory for this position. Proficiency in additional languages may be considered an asset but is not explicitly required.

Additional Notes:
The consultancy is based in Kabul, Afghanistan, with potential travel to various provinces. This vacancy notice may be used to identify candidates for other similar consultancies at the same level. Only candidates under serious consideration will be contacted, and a written test may be used as a form of screening. Candidates selected for interviews will need to provide scanned copies of their educational qualifications in advance. WHO is committed to creating a diverse and inclusive environment and encourages applications from women, persons with disabilities, and nationals of underrepresented Member States. The organization has a zero-tolerance policy towards sexual exploitation and abuse, and all members of the workforce are expected to adhere to the highest ethical standards. Consultants will work as independent contractors and are responsible for their own taxes and contributions. WHO requires proof of vaccination as a condition for assignment, except where a medical condition prevents vaccination.