Posted on: Fri 04-07-2025

Nina Jojer Limited is a Pan-African consulting firm committed to empowering transformation in Africa by providing innovative solutions to businesses, governments, and organizations. Our core services include Policy Development, Strategic Advisory, Stakeholder Management and Advocacy, Digital Transformation, and Data-Driven Insights. We are dedicated to driving impact and fostering long-term growth for our clients.

We are recruiting to fill the position below:

 

Job Title: Health Consultant

Location: Abuja (FCT)

Employment Type: Temporary

 

Background

• The National Agency for Food and Drug Administration and Control (NAFDAC) is responsible for ensuring the quality, safety, and efficacy of medicines through stringent regulatory and quality control measures.
• As Nigeria's National Medicines Regulatory Authority, NAFDAC has a functional and efficient WHO-PQ laboratory that complies with WHO standards. The Laboratory adheres to the Good Practices for Pharmaceutical Quality Control Laboratory (GPPQCL), to make decisions about the efficacy and quality of medical products procured with funds from the Global Fund for the Integrated ATM program during routine QA/QC activities. A key component of this process is the application of statistical data analysis to evaluate laboratory test results, assess product compliance, and support data-driven decision-making in regulatory processes.
• To strengthen its capacity in statistical data analysis for quality control (QC) activities, NAFDAC seeks the expertise of a consultant with extensive prerequisite experience in pharmaceutical statistical analysis, quality control, quality assurance, and regulatory compliance.

Justification:

• The purpose of the Terms of Reference is to define the responsibilities of the consultant and scope of engagement which includes statistical data analysis of the laboratory reports generated for ATM commodities.
• The consultant will provide technical assistance in the application of statistical methods for analyzing laboratory data on medicines, ensuring robust quality control practices and compliance with regulatory standards.

Specific objectives include:

• Conducting statistical analysis of pharmaceutical analytical data to assess quality trends and product compliance for the integrated sampling program for ATM products
• Supporting NAFDAC in establishing best practices for data-driven quality control decision-making with respect to the ATM commodities
• Developing statistical models and tools to improve data interpretation for regulatory purposes.
• Providing training to NAFDAC QC personnel on the application of statistical techniques in medicine quality assessment.

Main responsibilities and tasks

The consultant shall work closely with CDCL, NAFDAC to:

• Perform statistical evaluations of analytical laboratory data, apply statistical process control (SPC) techniques to assess trends in quality attributes of medicines. Conduct outlier analysis, process capability analysis, and acceptance criteria evaluation related to ATM commodities
• Assist in root cause analysis of out-of-specification (OOS) and out-of-trend (OOT) results (if need be) related to ATM commodities.
• Develop statistical models for risk-based quality control decision-making on tests conducted and Create templates and reporting formats for statistical analysis of QC data related to ATM commodities
• Establish standardized data analysis procedures of ATM commodities aligned with regulatory requirements (e.g., ICH, WHO,USP, ISO)
• Support capacity building for NAFDAC laboratory and regulatory staff on statistical methodologies for medicine quality assessment. Provide guidance on the use of statistical software (e.g., Minitab, JMP, SAS, R, or equivalent) for QC data analysis and Train personnel on data interpretation and regulatory reporting of statistical results.
• Prepare and submit reports on statistical findings and quality control trends related to ATM commodities
• Offer guidance on aligning statistical practices with international regulatory expectations.
• Make appropriate recommendations for improving data quality and decision-making processes to the Director- General of NAFDAC through the Director, Drug Laboratory Services, on any necessary regulatory actions and/or information dissemination related to medicine safety.

Deliverables:

• Statistical Analysis Reports – Detailed analysis of QC data, including trend analysis, OOS/OOT evaluations, and process capability assessments.
• Standardized Statistical Guidelines – SOPs and protocols for statistical analysis in medicine quality control
• Training Materials – Presentation slides, manuals, and hands-on exercises for capacity-building sessions and Report of NAFDAC QC staff capacity building
• Final Consultancy Report – A comprehensive report summarizing key findings, recommendations, and future action plans.

Requirements

Education:

• A Bachelor's or master’s degree in Statistics, Biostatistics, Pharmaceutical Sciences, Quality Assurance, or a related field. A PhD is desirable but not compulsory.
• At least 5–10 years of experience in statistical data analysis for pharmaceutical quality control or regulatory science.
• Strong knowledge of ICH, WHO, USP, and ISO guidelines related to medicine quality assessment.
• Proficiency in statistical software (e.g., Minitab, JMP, SAS, R, or equivalent).

Language:

English

Work experience:

• Experience in regulatory or pharmacopeial analysis in a laboratory or quality control setting.
• Demonstrated ability to train and mentor technical staff in QC Laboratory in statistical applications.

Application Closing Date

8th July, 2025.

 

How to Apply

Interested and qualified candidates should send their CV and cover letter to: [email protected] using the job title as the subject of the mail.

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