Senior Technical Advisor – Good -X - Practices

Senior Technical Advisor – Good -X - Practices

MAIN PURPOSE OF JOB

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.

Senior Technical Advisor – Good -X- Practices (STA-GXP) will under the leadership of the Country Program Director provide technical assistance to the DDA to strengthen regulation of medicines products in Nepal. The STA-GXP will support the update of the drug act, regulation, codes and guidelines to better positioning GXP and inspection and to ensure clear separation in roles and responsibilities between pharmacies, wholesalers and manufacturers and their licensing. The STA-GXP with assist the DDA in the revision and implementation of the 2005 guidelines and inspection tool for public- and private-sector retail pharmacies. The STA -GXP will collaborate with the professional bodies and organizations to provide understanding of GXP for implementation in the pharmacies and wholesalers to ensure implementation. The STA GXP will update DDA regulations to incorporate GDP compliance; revise and implement GDP guidelines for effective medicines quality assurance along the supply chain. The STA GXP will assist the STA PMIS and DDA to develop the DDA MIS for the inspection module starting with GPP and with the aim to integrate into PHARMADEX.  The STA GXP will support system documentation and the development of appropriate training materials.

MAIN DUTIES AND RESPONSIBILITIES

Technical Support 50%

• Support the legislative revision and update to strengthen  regulation and inspection of medicinal products
• Support the DDA to build regulatory capacity in inspection and licensing with focus on good pharmacy and good distribution practices.
• Develop and support in the 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 TA-CAP 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.
• Develop and implement training material for implementation of GXP guidelines for the management of medicines in government and private sector health facilities & pharmacies.
• Assist in the development of indicator-based inspection tools and guidelines
• Assess and improve interrater reliability linked to inspection
• Contribute to the design and implementation of field assessment activities related to the management of medicines including the analyses of data.
• 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 Ddesign and develop inspection reports and track performance at all levels
• Attend technical and program update meetings when required and support in the preparation of contents for such meetings.
• Assist in work plan development and progress reporting
• Perform other duties, as assigned.

Capacity Building 20%

• Participate in capacity assessments of government and private sector health institutions and their human resources and collaborate internally and externally to strengthen GXP implementation
• Contribute to the implementation of capacity building plans in GXP including their monitoring.
• IN collaboration with TA-CAP Cconduct training, coaching and supportive supervision as required.

Coordination 20%

• 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

Monitoring & Evaluation 10%

• In coordination with the MEL team support the program for the establishment of mechanisms for collecting relevant data to their established indicators. Also participate in program review activities and provide adequate recommendations.
• After introduction and in collaboration with the HR responsible take responsibility for the upload into the training databases
• Contribute to the adequate documentation and dissemination of program results and lessons learned, including the development and submission of project’s mandatory reports, technical documents and reports; and abstracts and articles for scientific journals and conferences.
• Support as needed the development of annual, quarterly and monthly update reports

QUALIFICATIONS

Education

Required: MSc degree in Pharmacy or other relevant master degrees

Preferred:

• Inspector or pharmacists with experience in implementation of good pharmacy practices, distribution practices and/ or manufacturing practices and inspections and quality assurance.
• The STA GXP should preferably have good understanding of survey design, data collection, indicators, data analysis and reporting

Experience

Required: At least seven years of relevant experience in areas of medicines management (supply chain, logistic management, dispensing and use), pharmaceutical inspection

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
• 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 written and verbal communication skills in English and Nepali are essential.
• 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.
• 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
• 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.

Interested candidates are requested to CLICK HERE to apply.