International/National Consultant – specialist for introduction of ISO standards
Tajikistan - Dushanbe
United Nations Development Programme
Tajikistan
TERMS OF REFERENCE
The Grants of the Global Fund to Fight AIDS, Tuberculosis and Malaria to Tajikistan
Project Titles:
Post Title: UNDP HIV, TB and Malaria Control Programme
International/National Consultant – specialist for introduction of ISO standards
Location: Dushanbe, Tajikistan
Type of contract SSA Contract
Duration:
Location: Dushanbe, Tajikistan
Instruction for submission of applications: Please fill out an Application form for SC/SSA positions posted on www.undp.tj by following the job vacancies link from this webpage. Please note that no other type of application form will be considered for such positions, other than the one found at the link specified above.
BACKGROUND INFORMATION
UNDP Tajikistan is the Principal Recipient of the grants under the Global Fund to fight AIDS, Tuberculosis and Malaria (GFATM) for 2004-2010. In 2009, the GFATM and NCC approved UNDP as PR for new Round 8 grant which is based on current achievements made in the program and also envisage further expansion of HIV and TB control activities in the country, along with elimination of malaria. Implementation of GFATM grants envisage a large volume of procurement of health and non-health products and goods, required by the National partners to implement different interventions for AIDS, TB and Malaria prevention and control.
Established in 2000, the laboratory functioning under the Center of the state control for pharmaceutical activity. It is the State laboratory to perform quality control of pharmaceutical, reagents hygiene and cosmetics products and issue Certificate of Analysis or Certificate of conformity. To date no internationally recognized after shipment QC procedures have been put at place in the RT.
The laboratory divided into three sections: 1) research and analysis of pharmaceutical products and medical items; 2) research and analysis of hygiene and cosmetics items; 3) microbiological section.
The Laboratory employed 13 specialists with laboratory degrees. In 2000 laboratory has been registered and certified by the TAJIKGOSSTANDARD with reference INTJ762.37100.03.381-2010
In 2010 11759 types of medicines and medical items and 12962 types of hygiene and cosmetics has been tested by the laboratory.
Overall Objective
Implementation of quality control system and obtaining internationally recognized certificate of accreditation
Specific Objectives
To provide a team of experts to carry out the following tasks:
1- Assessment of the compliance of the laboratory infrastructure and procedures with the accreditation requirements according to ISO 17025:2005.
2- Evaluation of the pharmaceutical laboratory management system including the consumption and supply procedures and drafting a detailed report of the findings, conclusions and the recommendations for a comprehensive management system.
Within the project is planned to assess and analyze capacities of existing Laboratory for control of quality of pharmaceutical products and implementation of ISO/IEC 17025 in future
Requested services:
1. Assessment of the compliance of the laboratory infrastructure and organization with the accreditation requirements according to ISO 17025:2005.
• Assessment must include a documented evaluation of the present pharmaceutical laboratory organization and infrastructure, with identification of necessary modifications and recommendations related to best practice in the field of pharmaceutical laboratory infrastructure and organization.
• Prepare the schedule of implementation of ISO/IEC 17025 standards.
• Support for the preparation of the budget in the stage of ISO implementation
2. Evaluation of the pharmaceutical laboratory management system including the consumables and supply procedures, and drafting a detailed report of the findings, conclusions and recommendations for a comprehensive management system.
• Documented evaluation of the present management system.
• Documented recommendations for the establishment of a comprehensive management system, including purchasing procedures, consumed material data input, stores system.
Expected outputs/deliverables:
1. Assessment of the compliance of the laboratory with the accreditation requirements according to ISO 17025:2005.
• Documented report including the modifications needs for laboratory sections and subsections to meet accreditation requirements according to ISO 17025: 2005. Report on the management (organizational structure, document control, staff capacity and legal status), technical requirements and existing methodology of analyses;
• Documented report for evaluation of the present organization and infrastructure.
2. Evaluation of the laboratory warehouse management system including the consumables and supply procedures, and drafting a detailed report of the findings, conclusions and recommendations for a comprehensive management system.
• Include in the report overview and recommendations on the purchasing procedures and the present management system.
• Documented recommendations for the establishment of a comprehensive management system, including purchasing procedures, consumed material data input, stores system.
• Developing detailed Action Plan and timeframe to pass certification process, including the list of needed activities, schedule of implementation, necessary actions to obtain ISO/IEC 17025 standard certificate. Preparation the budget for implementation of ISO standards and accreditation. Other recommendation for the implementation ISO standards and accreditation.
Qualifications and Experience
1. Advanced university degree in pharmacy, pharmacology, biomedical science or affiliated specialties.
2. A professional track record of at least 5 years in practice in Pharmaceutical, in health and non health products Quality Control and accreditation expertise.
3. At least 3 years of international experience introduction of ISO standards
4. Knowledge of Quality Assurance, Standardization, Conformity Assessment, Certification and Accreditation;
5. Specific experience on testing laboratories and training on ISO standards
6. Good technical skills in measurement and evaluation, including grasp of methodological and operational dimensions and the ability to link corporate and country level issues;
7. Excellent interpersonal, consultation, communication (both verbal and written), facilitation and presentation skills;
8. Excellent knowledge of English language, Russian is desirable.
Location and Duration:
Starting period: in March 2011
Foreseen finishing period or duration: 20 days (10 days in the field and 10 days home work) .
Location of assignment: the assignment will be carried out in pharmaceutical laboratory of Center of the state control for pharmaceutical activity, Dushanbe, Republic of Tajikistan.
Selection of the candidates will be based on cumulative analysis (highest qualified candidate)
Full version of ToR is available on UNDP website
Since UNDP Tajikistan currently has a majority of male employees, we strongly encourage qualified female applicants for this position. UNDP seeks to ensure that male and female employees are given equal career opportunities and that staff members are able to keep an appropriate balance between work and private life.
United Nations Development Programme
Tajikistan
TERMS OF REFERENCE
The Grants of the Global Fund to Fight AIDS, Tuberculosis and Malaria to Tajikistan
Project Titles:
Post Title: UNDP HIV, TB and Malaria Control Programme
International/National Consultant – specialist for introduction of ISO standards
Location: Dushanbe, Tajikistan
Type of contract SSA Contract
Duration:
Location: Dushanbe, Tajikistan
Instruction for submission of applications: Please fill out an Application form for SC/SSA positions posted on www.undp.tj by following the job vacancies link from this webpage. Please note that no other type of application form will be considered for such positions, other than the one found at the link specified above.
BACKGROUND INFORMATION
UNDP Tajikistan is the Principal Recipient of the grants under the Global Fund to fight AIDS, Tuberculosis and Malaria (GFATM) for 2004-2010. In 2009, the GFATM and NCC approved UNDP as PR for new Round 8 grant which is based on current achievements made in the program and also envisage further expansion of HIV and TB control activities in the country, along with elimination of malaria. Implementation of GFATM grants envisage a large volume of procurement of health and non-health products and goods, required by the National partners to implement different interventions for AIDS, TB and Malaria prevention and control.
Established in 2000, the laboratory functioning under the Center of the state control for pharmaceutical activity. It is the State laboratory to perform quality control of pharmaceutical, reagents hygiene and cosmetics products and issue Certificate of Analysis or Certificate of conformity. To date no internationally recognized after shipment QC procedures have been put at place in the RT.
The laboratory divided into three sections: 1) research and analysis of pharmaceutical products and medical items; 2) research and analysis of hygiene and cosmetics items; 3) microbiological section.
The Laboratory employed 13 specialists with laboratory degrees. In 2000 laboratory has been registered and certified by the TAJIKGOSSTANDARD with reference INTJ762.37100.03.381-2010
In 2010 11759 types of medicines and medical items and 12962 types of hygiene and cosmetics has been tested by the laboratory.
Overall Objective
Implementation of quality control system and obtaining internationally recognized certificate of accreditation
Specific Objectives
To provide a team of experts to carry out the following tasks:
1- Assessment of the compliance of the laboratory infrastructure and procedures with the accreditation requirements according to ISO 17025:2005.
2- Evaluation of the pharmaceutical laboratory management system including the consumption and supply procedures and drafting a detailed report of the findings, conclusions and the recommendations for a comprehensive management system.
Within the project is planned to assess and analyze capacities of existing Laboratory for control of quality of pharmaceutical products and implementation of ISO/IEC 17025 in future
Requested services:
1. Assessment of the compliance of the laboratory infrastructure and organization with the accreditation requirements according to ISO 17025:2005.
• Assessment must include a documented evaluation of the present pharmaceutical laboratory organization and infrastructure, with identification of necessary modifications and recommendations related to best practice in the field of pharmaceutical laboratory infrastructure and organization.
• Prepare the schedule of implementation of ISO/IEC 17025 standards.
• Support for the preparation of the budget in the stage of ISO implementation
2. Evaluation of the pharmaceutical laboratory management system including the consumables and supply procedures, and drafting a detailed report of the findings, conclusions and recommendations for a comprehensive management system.
• Documented evaluation of the present management system.
• Documented recommendations for the establishment of a comprehensive management system, including purchasing procedures, consumed material data input, stores system.
Expected outputs/deliverables:
1. Assessment of the compliance of the laboratory with the accreditation requirements according to ISO 17025:2005.
• Documented report including the modifications needs for laboratory sections and subsections to meet accreditation requirements according to ISO 17025: 2005. Report on the management (organizational structure, document control, staff capacity and legal status), technical requirements and existing methodology of analyses;
• Documented report for evaluation of the present organization and infrastructure.
2. Evaluation of the laboratory warehouse management system including the consumables and supply procedures, and drafting a detailed report of the findings, conclusions and recommendations for a comprehensive management system.
• Include in the report overview and recommendations on the purchasing procedures and the present management system.
• Documented recommendations for the establishment of a comprehensive management system, including purchasing procedures, consumed material data input, stores system.
• Developing detailed Action Plan and timeframe to pass certification process, including the list of needed activities, schedule of implementation, necessary actions to obtain ISO/IEC 17025 standard certificate. Preparation the budget for implementation of ISO standards and accreditation. Other recommendation for the implementation ISO standards and accreditation.
Qualifications and Experience
1. Advanced university degree in pharmacy, pharmacology, biomedical science or affiliated specialties.
2. A professional track record of at least 5 years in practice in Pharmaceutical, in health and non health products Quality Control and accreditation expertise.
3. At least 3 years of international experience introduction of ISO standards
4. Knowledge of Quality Assurance, Standardization, Conformity Assessment, Certification and Accreditation;
5. Specific experience on testing laboratories and training on ISO standards
6. Good technical skills in measurement and evaluation, including grasp of methodological and operational dimensions and the ability to link corporate and country level issues;
7. Excellent interpersonal, consultation, communication (both verbal and written), facilitation and presentation skills;
8. Excellent knowledge of English language, Russian is desirable.
Location and Duration:
Starting period: in March 2011
Foreseen finishing period or duration: 20 days (10 days in the field and 10 days home work) .
Location of assignment: the assignment will be carried out in pharmaceutical laboratory of Center of the state control for pharmaceutical activity, Dushanbe, Republic of Tajikistan.
Selection of the candidates will be based on cumulative analysis (highest qualified candidate)
Full version of ToR is available on UNDP website
Since UNDP Tajikistan currently has a majority of male employees, we strongly encourage qualified female applicants for this position. UNDP seeks to ensure that male and female employees are given equal career opportunities and that staff members are able to keep an appropriate balance between work and private life.
How to apply
Instruction for submission of applications: Please fill out an Application form for SC/SSA positions posted on www.undp.tj by following the job vacancies link from this webpage. Please note that no other type of application form will be considered for such positions, other than the one found at the link specified above.
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