Technical Advisor - Inspection

Overall Responsibilities:

The goal of the global five-year USAID Medicines, Technologies and Pharmaceutical Services (MTaPS) Program is to help low- and middle-income countries to strengthen their pharmaceutical systems to ensure sustainable access to and appropriate use of safe, effective, quality-assured, and affordable essential medicines and pharmaceutical services. MTaPS, implemented by Management Sciences for Health (MSH) and partners, will provide technical assistance to the Ministry of Health and Population (MOHP) and the Department of Drug Administration (DDA) including other relevant implementing agencies to strengthen pharmaceutical systems including pharmaceutical sector governance, regulatory systems, pharmaceutical management information systems, and improve patient-centered pharmaceutical services.

Technical Advisor – Inspection (TA-Inspection) will under the leadership of the Principle Technical Adviser GXP provide technical assistance to the DDA to strengthen medical products regulation and regulatory inspections in Nepal. The TA-Inspection will support the update of inspection regulation, codes, guidelines and inspection tools to provide strategies for application of Good Pharmacy Practices (GPP) and Good Dispensing Practices (GDP) inspection and to ensure clear separation in roles and responsibilities between pharmacies, wholesalers and importers and their licensing. The TA-Inspection will assist the DDA in the implementation of the new inspection management information system in Pharmadex, to develop inspection reports and monitor performance. The TA-Inspection will assist in implementation of innovative strategies to promote and create awareness of the new GPP and GDP and will in collaboration with the professional bodies provide a better understanding of GPP in pharmacies and in the community. The TA-Inspection will support system documentation and the development of appropriate training materials and standard operating practices (SOP) in line with the DDA quality management system.

Technical Support (50%)

• Support the legislative revision to strengthen regulatory inspections.
• Support the DDA to build regulatory capacity in inspection and licensing with focus on good pharmacy and good distribution practices.
• Develop innovative strategies and support implementation of guidelines and standard operating procedures to strengthen GXP at central and provincial DDA level.
• Support the implementation of the DDA quality management system especially in the area of inspection.
• In collaboration with the PTA-GXP develop training material and implement training for implementation of GXP guidelines and standard operating procedures for the DDA staffs and inspectors at central and provincial level.
• Assist in orientation and development and implementation of advocacy activities for implementation of the new GPP in private sector pharmacies.
• Assess and improve interrater reliability linked to inspection.
• Assist in the design, development and use of the pharmaceutical management information system for the inspection module including inspection data entering, recording, monitoring and reporting.
• Assist DDA to design and develop inspection reports and track performance at all levels.
• Assist in work plan development and progress reporting.
• Perform other duties, as assigned.

Capacity Building (25%)

• Participate and assist the PTA in capacity building for inspectors at central and provincial DDA level.
• Support activities aimed at building GPP awareness and advocacy in private sector pharmacies and communities.
• Contribute to the implementation of capacity building plans in GXP including their monitoring.
• In collaboration with PTA-GXP conduct training, coaching and supportive supervision as required.

Coordination (25%)

• Coordinate with other MTaPS Nepal technical activities ensuring harmonized approach in line with MSH quality standards.
• Maintain close liaison and coordination with senior officials in the MOHP and DDA and other key stakeholders e.g., WHO, USAID implementing partners, to ensure technical assistance activities are carried out with their active participation for building ownership.
• Work closely with Management Division, the Ministry of Social Development in the provinces, external development partner supply chain working group, government and private sector health facilities & pharmacies and pharmaceutical organisation, wholesalers’ organisations and medicines manufacturers association.
• Work closely with private sector to strengthen GXP implementation.

REQUIRED MINIMUM EDUCATION

Required:

MSc/BSc degree in Pharmacy

Preferred:

Inspector or pharmacist with experience in implementation of good pharmacy practices, good distribution practices and regulatory inspections.

The TA Inspection should preferably have good understanding of regulation, guideline and SOP development and implementation through advocacy and training.

REQUIRED MINIMUM EXPERIENCE

Required:

• At least 4 yrs+MSc / 6 yrs+BSc of relevant experience in areas of inspection, medicines regulation and quality assurance.

Preferred:

• Experienced in the use of various capacity building methods and approaches.
• Experience in supervision, facilitation and motivation.
• Experience with indicator-based tools, data collection and analysis.
• Strategic Planning and organisational experience.

KNOWLEDGE AND SKILLS

• Strong people skills with the ability to develop others and to impart knowledge and experience in clear and respectful manner according to the stakeholder needs.
• Mentoring, training and coaching abilities.
• Facilitation and training skills.
• Strong collaboration and advocacy skills.
• Strong analytical and research skills preferred.
• Strong documents, presentations and training skills.
• Excellent English writing and reporting skills.
• Excellent verbal communication skills in English.
• Demonstrated intermediate skills in Microsoft Office Suite applications, including Word, Excel, PowerPoint and and electronic data management tools.
• Strong organizational skills with the ability to handle multiple tasks simultaneously.

COMPETENCIES

• Ability to work independently and effectively in a team.
• Good judgment for decision making.
• Strong interpersonal and communication skills; ability in consensus building and work planning.

PHYSICAL DEMANDS

• Travel requirements up to 40% at national levels.
• Keyboard use, pulling drawers, lifting papers <10 lbs., etc.

MSH is an equal opportunity employer and will not discriminate against any employee or applicant for employment on the basis of race, color, sex, sexual orientation, gender or gender identity, religion, creed, citizenship, national origin, age, veteran status, or disability unrelated to job requirements. MSH will take affirmative action to ensure that qualified applicants are employed and that employees are treated without regard to their race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran and disability status. In compliance with U.S. Department of Labor Executive Order 11246, Section 503 of the Rehabilitation Act, and Section 4212 of the Vietnam Era Readjustment Assistance Act, MSH has developed and maintains an affirmative action program and plan.

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