Background

Background

The Medicines Control Authority of Zimbabwe (MCAZ), is the country’s sole regulatory authority of medicines and allied substances, through an act of Parliament, the Medicines and Allied Substances Control Act (MASCA) [Chapter 15:03]. The Authority is mandated through this act to ensure that safe and effective medicines and allied substances are supplied onto the Zimbabwean market, through pre and post market surveillance amongst some of its various regulatory requirements processes.

The MCAZ Microbiology is responsible for microbiological analysis of pharmaceutical preparations before and after they are distributed in the country. Currently, the Microbiology Laboratory performs three (3) test methods namely;

1. Microbiological Assay of Antibiotics,
2. Sterility Test (parenterals and ophthalmic preparations),
3. Microbiological Examination of Non-Sterile Products

In 2015, a World Health Organization (WHO) consultant performed an assessment, evaluation and review of the MCAZ Microbiology laboratory to check compliance of its management system and working standards against WHO Good Practices for Pharmaceutical Microbiology Laboratories. The WHO consultant made a recommendation to the Medicines Control Authority of Zimbabwe (MCAZ) Management to renovate the Microbiology Laboratory in line with WHO Prequalification requirements. The Microbiology Laboratory was under remodeling for the past three (3) years and the project was funded by Global Fund and managed through the United Nations Development Programme (UNDP). The project was completed and handed over to MCAZ on the 5th of February 2021 by the contractors after a WHO technical consultant virtually assessed the remodeled laboratory against the WHO Prequalification requirements, and found to be structurally compliant.

The Medicines Control Authority of Zimbabwe intends to have the Microbiology Laboratory assessed for WHO prequalification by the end of 2022. In preparation for the prequalification assessment, the laboratory is currently developing a Quality Management Systems (QMS) in line with requirements of WHO prequalification. The laboratory has limited experience in developing documentation for prequalification. It is against this background that the laboratory is seeking for technical assistance in developing QMS documentation that meets WHO requirements as well as a roadmap for WHO prequalification.

Objective of the assignment:

The objective of the consultancy is to assist the MCAZ Microbiology laboratory in developing Quality Management System (QMS) documentation that meets WHO Prequalification requirements and a roadmap for WHO prequalification of the Microbiology Laboratory

Duties and Responsibilities

Scope of work

The assignment will involve assessment of the current documentation and identification of gaps in order for the QMS to meet WHO Requirements. The consultant will be required to assist the Laboratory to address the identified gaps. In performing these tasks, the consultant shall use the following guidance documents

1. WHO Technical Report Series No. 961, 2011 Annex 6: WHO good Manufacturing practices for sterile pharmaceutical products;
2. WHO Technical Report Series No. 957, 2010 Annex 1: WHO good practices for pharmaceutical quality control laboratories;
3.  WHO Technical Report Series No. 961, 2011 Annex 2: WHO good practices for pharmaceutical microbiology laboratories.
4. Any other relevant standards

1. Duties and Responsibilities

The consultant shall;

1. Review the available QMS documentation for compliance to WHO prequalification and identify gaps. The gaps may include but not limited to; missing standard operating procedures, forms and protocols; inadequately written standard operating procedures, forms and protocols. 
2. Write a report on the identified gaps and present to the Microbiology Laboratory and MCAZ Management, highlighting critical areas and the identified gaps.
3. Assist personnel in the Microbiology Laboratory to address the gaps by providing technical assistance in development of missing documents and reviewing of QMS documents that do not meet WHO prequalification requirements.
4. Train MCAZ Microbiology personnel on the implementation of the developed and reviewed QMS documentation.
5. Write a report on the level of compliance of the MCAZ Microbiology Laboratory upon completion of the tasks.
6. Liaise with MCAZ Laboratory focal person(s) throughout the duration of the consultancy to understand their needs.

institutional Arrangement

The consultant will report to UNDP and MCAZ focal personnel

Expected Outputs and Deliverables

Duration of Assignment, Duty Station and Expected Place of Travel

 Contract duration: 3 months

The assignment will involve a site assessment of the facility to allow the consultant to familiarize with the new facility. The site assessment can be done physically or virtually depending on feasibility. Virtual meetings can also be conducted for the other engagements. 

Competencies

• Project and Resource Management: Ability to work independently, produce high quality outputs.   
• Partnership building and teamwork:   Provides constructive coaching, feedback and team building.  
• Communications and Advocacy: Strong ability to write clearly, adapting style and content to different audiences and speak clearly and convincingly. 1. Strong capacity to communicate clearly and quickly.  2. Strong communication skills, including ability to produce high quality practical advisory reports and knowledge products

Required Skills and Experience

Education:

• Advanced degree or equivalent in Biology, biomedical sciences, pharmaceutical sciences or related field.

Experience:

• At least 10 years’ experience in a WHO Prequalified Pharmaceutical Microbiology Laboratory.
• Good knowledge of SOP writing, QMS development and implementation for WHO PQ Lab requirements.
• Good knowledge of WHO norms and standards and on prequalification for Microbiology Labs.

Language

• Excellent oral and written English.  

Candidates will be evaluated using a combined scoring method with the qualifications and methodology weighted at 70% and the price offer weighted at 30%.  Only candidates obtaining a minimum of 49% (out of 70%) points on the technical qualifications part will be considered for the Financial Evaluation.

Criteria for evaluation of qualifications and methodology (70 points maximum):

•     Relevance of education to the consultancy (10 points);
•     Demonstrable experience in facilitating advocacy workshops for CSOs in Zimbabwe (20 points)
•     Sound understanding of prevailing trends of issues in HIV/TB and Malaria Programming (10 points)
•     Experience in communication, documentation and in developing Manuals, or Advocacy Plans (30 points)

Criteria for financial evaluation (30 points maximum)