INDIVIDUAL CONSULTANT- Prequalification of condoms and TCu380A IUDs, UNFPA, remote

Hiring Office:

Supply Chain Management Unit

Purpose of consultancy:

The role of consultant will be as part of the WHO/UNFPA Prequalification Team of Supply Chain Management Unit (SCMU) to assess  products conformity to generic technical specifications, quality, efficacy and safety standards. More in detail, the consultant will support UNFPA’s work collaboratively and in partnership with WHO and other partners to develop guidelines providing technical guidance on prequalification, quality assurance, quality control, clinical studies and regulation of male and female condoms and IUDs. This work requires the use of technical experts and technical advisors with detailed knowledge and experience in these areas.  

Scope of work:

(Description of services, activities, or outputs)

1. Research, guideline development, and training services related to male condom, female condom and/or TCu380A IUD 

1. Draft technical documents, including statements and guidelines referencing the latest available scientific data and evidence.

2. Update specifications and guideline documents for male and female condoms and IUDs to align with current ISO standards for male and female condoms as well as IUDs. 

3. Perform research, desk reviews, systematic reviews and data analysis as required.

4. Provide satisfactory draft guideline documents or documents commissioned by UNFPA within the time period agreed between the two parties. 

5. Develop training agendas, training materials, and training exercises

6. Deliver the training

7. Provide technical support and guidance to meeting or workshop participants as deemed necessary by UNFPA

8. Provide inputs to meeting reports of workshop if applicable

1. Male, female condom or TCu380A IUD prequalification – technical documentation assessment and on-site inspection services

1. Develop an inspection programme for submission to UNFPA three weeks in advance of any scheduled inspection. 

2. Conduct an on-site or a remote factory inspection in the capacity of either Lead Inspector or Co-Inspector covering the following in line with the requirements detailed in the male latex condom technical specification or the female condom generic specification, or the TCu380A IUD technical specification and supporting guidelines and SOPs

3. Sampling of condoms from 3 random Lots according to sampling procedures in ISO 2859. 

Deliverables:

1. Research, guideline development, and training services related to male condom, female condom or TCu380A IUD 

1. Documents developed within set timelines and in accordance with UNFPA and WHO guidelines

2. Research reports submitted within specified timelines

3. Training material developed within stipulated timelines

4. Training delivered 

5. Training and meeting reports completed within set timelines

1. Male, female condom or TCu380A IUD prequalification – technical documentation assessment and on-site inspection services

1. Technical file assessment reports

2. Inspection plans

3. Inspections conducted

4. Inspection reports

5. Assessment reports of Corrective Action and Preventive Action documents

6. Drafted Notices of concern etc.

Duration and working schedule:

ROSTER: part-time of about 30 hours per month

Duration of contract: Variable depending on workload

Place where services are to be delivered:

Remotely from home

Delivery dates and how work will be delivered (e.g. electronic, hard copy etc.):

Electronic reports and documents

Delivery dates will be as per PQ programme SOPs and timelines

Monitoring and progress control, including reporting requirements, periodicity format and deadline:

After each assignment the IC will submit deliverables as per the agreed timelines.

Supervisory arrangements: 

Remote supervision

Expected travel:

Yes, when pandemic travel restrictions permit

(Travel costs to be covered by UNFPA as per applicable policies and procedures)

Remuneration

USD 200-250 per day

Required expertise, qualifications and competencies, including language requirements:

Education:  

University degree in Chemistry, Biomedical Technology, Biochemistry, Material Science, Epidemiology, Biostatistics, Engineering, Pharmaceutical, Clinical Research, Biotechnology, Microbiology, Public Health, or related subject

 Knowledge and Experience: 

• A minimum of 7 years of experience in one or more of the following: quality management systems for any contraceptive device manufacturing or contraceptive device manufacturing production processes or inspections, or clinical trials and review of clinical safety and efficacy data of condoms, or quality control of contraceptive devices.

Desirable:

• Sound knowledge of the WHO/UNFPA prequalification process

• Experience in conducting inspections for a national regulatory authority or in conducting ISO 13485 audits for condoms is an asset

• Certification in ISO 13485 audits or Good Manufacturing Practice inspections with documented evidence of knowledge in male or female condoms or IUDs as required for factory inspections.

• Previous similar experience working for UNFPA or International agency or public sector agency is an asset

• Training on ISO 14001 auditing is an asset 

Languages: 

• Fluency in English as demonstrated through previous formal training, qualifications, or work experience.

• Fluency in French, Spanish or Chinese is an asset

.

Inputs / services to be provided by UNFPA or implementing partner (e.g support services, office space, equipment), if applicable:

Email address, and access to UNFPA cloud repositories

Other relevant information or special conditions, if any:

Requirement to attend the quarterly virtual meetings for PQ programme consultants