Technical Advisor - Good Pharmacy Practices

Technical Advisor - Good Pharmacy Practices

(Only for Nepalese Nationals)

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, good pharmacy practices, regulatory systems, pharmaceutical management information systems, and improve patient-centered pharmaceutical services.

The TA - GPP will carry out the GPP intervention strategy activities which will strengthen GPP implementation in the private sector pharmacies in Nepal. The TA-GPP will under the guidance of the Principle Technical Advisor Good Pharmacy Practices, assist in the implementation of the multi-pronged GPP implementation strategy in collaboration with the Department of Drug Administration (DDA) and key stakeholders.  

LOCATION

The TA-GPP will be situated in Kathmandu and will be traveling to the DDA branch offices as needed

Technical Support (40%)

• Support the legislative revision and update of the codes for Sale and Distribution (CSD) to strengthen pharmacy regulation and inspection, to increase the registration validity period and increase registration and renewal fees.
• Update the CSD to specify roles of pharmacies and wholesales and to establish mechanisms to control that procurement move to and from registered entities only.
• Update CSD to include pharmacy classes A, B, C and include in the Pharmadex registration requirements and in the updated registration guidelines. Link to the staffing requirements for registration and inspection requirements.
• Finalize GPP guidelines and include in the CSD and make GPP inspection requirements to be mandatory after limited introduction time for Type A and B pharmacies. Print and avail the GPP guidelines and build capacity in GPP guidelines.
• Classify all indicators into critical, major and minor and link to CSD and the mandatory requirements and inspection tool and guidelines. Finalize and implement electronic GPP inspection tool.
• Support to finalize and implement Pharmadex pharmacy registration module and develop reporting formats. Update pharmacy registration guidelines.
• Support the implementation of the DDA quality management system especially in the area of inspection and pharmacy registration.
• Agree on inspection reporting format and integrated/upload summary report into Pharmadex. Support linking the inspection section and pharmacy registration through Pharmadex. Identify and describe reporting and data analysis needed and customize inspection and pharmacy registration reports to strengthen regulation and inspection.
• Hold meetings with pharmacy associations to explore the appropriate strategy i.e. drug shop concept in other countries to strengthen the GPP implementation in Nepal.
• Assist in the development of indicator-based inspection tools and guidelines.

Capacity Building (35%)

• Organize training for DDA inspectors in the GPP guidelines, legislative changes and in the electronic GPP inspection tool and inspection reporting.
• Organize training for DDA inspectors in use of Pharmadex in pharmacy registration, modification and renewal and in report generation.
• Develop GPP, CSD and GPP guidelines e-learning course and discuss with DDA and professional bodies how the course can best become a requirement for pharmacy registration and renewal. Develop e-learning course for use of Pharmadex.
• Develop QMS manual and SOP for pharmacy practices with help from local consultant and organize training of professional bodies tutors and make the manual and SOP available.
• Develop a training program for TOT from the professional bodies and train tutors and implement practical training.
• Support developing a manual on GPP guidelines for GPP implementation.
• Develop and implement IEC strategy for community awareness of new GPP and CSD requirements.

Coordination (35%)

• Work closely with other MTaPS team members to ensure technical work plans are being implemented in a timely and technically sound manner, and productively leverage collaboration with key government and other stakeholders and partners.
• Organize meetings with the DDA and professional bodies as needed.
• Design, produce and provide the reward to GPP certified facilities and design appropriate implementation strategy.
• Prepare and implement a cost sharing scheme, agree with DDA inspectors and implement.
• Manage the implementation of the GPP strategy in close collaboration with DDA and the MTaPS TA-Good -Pharmacy-Practices.

REQUIRED MINIMUM EDUCATION

Bachelor’s or master’s degree in pharmacy is required as well as at least four years of experience in community pharmacy, spearheading GPP compliance, conducting inspections and improving pharmaceutical regulation.

REQUIRED MINIMUM EXPERINCE

• At least four years of relevant experience in the areas of pharmacy practices and regulation.

Preferred

• Experience in GPP implementation and inspection.

KNOWLEDGE AND SKILLS

• Knowledge of Nepal’s pharmaceutical sectors and community pharmacies performance and challenges.
• Knowledge of the World Health Organization GPP best practices and the Nepal National GPP guidelines.
• Knowledge of the drug law and Code of Sales and Distribution.
• Understanding of Nepal’s pharmacy registration and regulation policies, laws and guidelines.

COMPETENCIES

• Strong networking, collaboration, and advocacy skills.
• Excellent interpersonal skills.
• Excellent written and verbal communication skills in both English and Nepali are essential.
• Excellent skills in report writing and minute-taking abilities.
• Strong organizational skills including the ability to handle multiple tasks simultaneously and organize meetings.
• Ability to work independently as well as effectively in a team.
• The ability to build consensus within a team and constructively lead activity implementation.
• Significant relevant experience in pharmaceutical systems especially in regulatory affairs, GPP inspection and pharmacy registration.
• Demonstrated intermediate proficiency in Microsoft Office Suite applications such as Word, Excel and PowerPoint.

PHYSICAL DEMANDS

• Travel requirements are limited but may include travels to branch offices.

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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