|Date Posted:||Jun 21, 2017|
|Closing Date:||Jun 29, 2017|
|Work Type:||Full Time|
|Number of Vacancies:||1|
|Salary Range:||As per NTA salary scale policyNone|
|Years of Experience:||5 Years|
|Contract Duration:||Not specified|
|Contract Type:||Service Contract|
|Probation Period:||3 months|
About National Medicine and Healthcare Products Regulatory Authority:
National Medicine and Healthcare Products Regulatory Authority (NMHRA) functions to regulate medicine and Healthcare Products in Afghanistan. NMHRA is aimed to ensure availability of effective and safe medicine and healthcare products with high quality and fair prices. It works to manage and control production, import, delivery and distribution of medicine and healthcare products to ensure efficacy, safety and quality. The authority develops and implements effective standards for improving safety, effectiveness, quality and ease of access to medicine and healthcare products throughout the country. Core functions of NMHRA includes developing and enforcing medicine and healthcare products related rules, regulations and policies, licensing businesses and professionals, registration and control of medicine and Healthcare Products including Narcotics and Psychotropic drugs, pre and post market quality control and surveillance, regulation and control of advertisements and publicity, determination and control of prices, and clinical trials regulation and control.
Scope of services:
The Quality Assurance Adviser will assist the director of the Medicine and Healthcare Products Quality Control Laboratory on developing and implementing the long term quality control and quality assurance vision, quality policies & standard operating procedures, data management and documentations systems in accordance to the international quality controls accreditation criteria
Quality Assurance Advisor will be responsible for the technical issues of QC Lab and appropriateness of all analytical work for testing quality of medicines and health care products
Duties & Responsibilities:
1. Review and improve the existing Quality Manual, SOPs, Matrixes, documentation systems and records
2. Support and coordinate the quality program accordance with the laboratory quality manual, including its implementation systems and procedures.
3. Ensure from the appropriateness of validation and calibration procedures.
4. Support and provide technical assistance on implementation of training programs.
5. Fulfil the quality control analysis on medicine and healthcare products when required.
6. Work with QC Lab procurement process to integrate quality standards as part of the procurement of chemicals and equipment.
7. Investigate and record customer complaints regarding DMHQCL performance, and results
8. Prepare monthly summaries of quality issues and present to the senior DMHQCLstaff
9. Communicate to coordinate the DMHQCL quality issues with relevant stakeholders and building external relations
10. Provide technical assistance in achievement of the ISO 17025 accreditation.
11. Activity planning and reporting in coordination with the DMHQCL leadership team
12. Implement the developed SOPs in the DMHQCL
13. Provide support to QCL Director for initiating changes to QC technical process & QCL setups
14. Develop and apply proper SOPs, policies, bills and guidelines for the testing of medicine and healthcare products according to the international best practices.
15. Perform any other task as required by the director of DMHQCL
1. Bachelor degree in pharmacy, master degree in related field is preferred.
2. At least Five years of working experience with government or Non-Governmental Organization or UN agencies in the field of Laboratory, supply chain management or quality assurance of pharmaceuticals. Working experience in quality assurance of medicine and healthcare products is highly preferred.
3. Excellent written and verbal communication skills in English language and fluent in a local language;
4. Having computer skills of MS office programs.