Senior Special Advisor for Quality Assurance, Ministry of Health-Ethiopia Vacancy Announcement; February 7 2024
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Organization: Ministry of Health-Ethiopia
Position: Senior Special Advisor for Quality Assurance
Location: Addis Ababa
Employment: Full time
Salary: 111690.00 (One hundred eleven thousand six hundred ninety)
Date of Announcement: February 6 2024
Deadline: February 19, 2024
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Job Description
Ministry of Health would like to invite competent and interested applicants for the following positions.
Reports to: Senior Special advisor, Project Technical lead
Employment Type and Duration: The contract duration will be for 36 [thirty six] months, renewable annually subject to performance and budget availability
Required Number: 1 (One)
Background
The COVID-19 pandemic has thought the world how sustainable and widely available vaccine manufacturing capacity is critical. For Africa and other LMICs, having local vaccine manufacturing capacity and capability will help to ensure supply security, control over production scheduling and sustainability, control of costs, socio-economic development, and rapid response to local epidemics including emerging infectious diseases. Thus comes the initiative of the Africa CDC/PAVM with the ambitious goal of African manufacturers producing 60% of the vaccine needed in the continent by 2040. This goal will be achieved through strengthening local capacity of member countries. The government of Ethiopia has therefore a huge interest and makes concrete steps to establishing cGMP compliant local vaccine manufacturing facility in Ethiopia by expanding the local capacity of vaccine manufacturing at the National Veterinary institute which has the capacity of manufacturing over 20 different vaccines for animal use. The Goal is to manufacture at least one vaccine (DP) by 2026 and one vaccine drug substance by 2027. So far, the initiative of the Ethiopian government has achieved major milestones including: development of feasibility study (technical, financial, and market), securing funding to finance the project. Moreover, based on the type of vaccine to be produced potential technology partners for technology transfer has been identified. The process of company formation (as government-owned facility with the support of technology partners) is on its final stage. A 20,000sqm of land within Kilinto Industrial Park is secured in the outskirt of Addis Ababa. Along with all preparatory activities, a recruitment of a consultancy firm is under way to begin the facility design and construction within the Industrial Park. Concerning the regulatory capacity, WHO has recently audited the EFDA to qualify for ML3; will receive the ML3 as soon as EFDA complies with the recommendations given by WHO. In order to strengthen other vaccine manufacturing ecosystems, the Ministry of Health is working closely with Africa CDC/PAVM in different platforms since the launching of PAVM in 2021.
The Ministry of Health of Ethiopia is now planning to recruit key personnel for the project office to coordinate and lead the different activities that support the establishment. One of the positions is Senior Special Advisor for Quality Assurance. .
Job description summary
The Quality Assurance Lead, dedicated to the vaccine manufacturing construction project, will play a vital role in upholding the highest standards of quality, compliance, and regulatory adherence throughout the entire construction process. Their primary objective will be to develop and implement robust quality systems and processes specifically tailored to the unique requirements of vaccine manufacturing. Working closely with cross-functional teams including architects, engineers, contractors, and regulatory authorities, the Quality Assurance Lead will ensure that the construction activities align with regulatory guidelines and industry best practices. They will diligently monitor the construction process, conduct inspections, and implement quality control measures to verify compliance with defined specifications and standards. Additionally, the Quality Assurance Lead will address any quality incidents or non-conformities, implementing corrective and preventive actions as necessary. Their expertise will contribute to the successful establishment of a state-of-the-art vaccine manufacturing facility that meets the highest quality and regulatory standards.
Duties and responsibilities
- Being accountable to the project technical lead, the Quality Lead shall have the following duties and responsibilities but not limited to, include
- Develop and implement a comprehensive quality assurance program to ensure compliance with applicable regulations, guidelines, and standards throughout the construction of the vaccine manufacturing facility.
- Review and provide input on architectural and engineering designs to ensure that quality requirements, such as cleanroom specifications, utility systems, and equipment layout, are adequately addressed
- Establish and maintain quality-related documentation, including standard operating procedures (SOPs), quality manuals, and specifications, ensuring alignment with regulatory requirements and industry best practices.
- Collaborate with cross-functional teams, including architects, engineers, contractors, and regulatory authorities, to ensure quality considerations are integrated into the construction process.
- Conduct risk assessments to identify potential quality risks during the construction phase and develop mitigation strategies to minimize their impact.
- Establish and monitor quality control measures, including inspections, testing, and validation activities, to ensure compliance with defined specifications and standards.
- Coordinate and participate in quality audits, both internal and external, to evaluate compliance with quality management systems and identify areas for improvement.
- Provide guidance and training on quality assurance principles, practices, and regulations to construction personnel and subcontractors involved in the project.
- Monitor and evaluate the performance of contractors and subcontractors, ensuring that they meet quality requirements and adhere to established quality plans.
- Investigate and address any quality incidents or non-conformities that arise during the construction phase, implementing corrective and preventive actions as necessary.
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Job Requirements
Educational Background
- Master’s degree or Bachelor’s degree in pharmacy, chemistry, or pharmaceutical engineering.
- Additional certifications or specialized training in utilities engineering would be advantageous.
Work Experience
- 15 years of proven experience in manufacturing and quality assurance for a Masters degree or 17 years of proven experience in manufacturing and quality assurance for a Bachelor’s degree.
PROFESSIONAL KNOWLEDGE, SKILLS AND ATTRIBUTES, REQUIRED
- In-depth knowledge of quality assurance principles, regulations, and standards relevant to the pharmaceutical industry, with specific expertise in vaccine manufacturing.
- Proven experience in quality assurance roles within construction projects, preferably in pharmaceutical or vaccine manufacturing facilities.
- Strong understanding of regulatory requirements and guidelines, including GMP, ISO standards, and local regulatory agencies.
- Familiarity with quality management systems, such as ISO 9001, and the ability to implement and maintain them effectively.
- Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams, contractors, and regulatory authorities.
- Attention to detail and strong analytical skills to identify quality risks, deviations, and opportunities for improvement.
- Strong problem-solving and decision-making abilities to address quality-related challenges and implement corrective actions.
- Knowledge of quality control and testing methodologies, as well as statistical techniques for data analysis.
- Strong organizational and time management skills to ensure quality assurance activities are integrated into the construction project timeline.
- Both the Civil service and MoH Human Resource Administration rules and regulations will be applied to guide the day to day services of the advisor.
- *As new priories emerge, MoH may periodically revise the TOR for this position.
How to Apply
Interested and qualifying applicants are invited to submit their application indicating the Title of the Position, non-returnable CVs and copies of their educational and work experience credentials together with original documents to Competency and Human Resource Administration Executive Officer, from January 2, 2024 to January 15, 2024. Qualifying women are encouraged to apply. If you fail to follow the instructions, you will be disqualified from the competition! We strongly encourage qualifying women to apply.
Competency and Human Resource Administration
Executive Officer, First Building, Ground Floor
Ministry of Health-Ethiopia, Addis Ababa
“NB:- If you have applied for this position and would like to stay informed about the recruitment process, please follow this link.: https://t.me/MoHHRRI“
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My name is Taju seid and I have master degree in clinical pharmacy
I have master degree in clinical pharmacy