MINIMUM QUALIFICATIONS AND REQUIREMENTS

Applicants must meet the following criteria:

1. Professional Qualification – Minimum of a degree in Pharmacy.

Higher qualifications (e.g., postgraduate degrees, higher diplomas, or equivalent specialization in Quality Assurance, Regulatory Affairs, or Pharmaceutical Sciences) will be considered desirable.

2. Audit Experience – At least 10 GMP audits conducted within the last 5 years.

3. Language Proficiency – Excellent fluency in English (written and spoken).

4. WHO GMP Competence – Proven track record of conducting audits in line with the WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles, including:

a. WHO TRS No. 986, Annex 2, 2014

b. WHO TRS No. 1025, Annex 2, 2020

DESIRABLE QUALIFICATIONS AND EXPERIENCE

In addition to the above, the following will be considered an advantage:

1. Local and Regional GMP Proficiency – Applied understanding of:

a. Kenya Pharmacy and Poisons Board (PPB) Good Manufacturing Practices Guidelines, 2022

b. East African Community (EAC) Guidelines on Good Manufacturing Practices for Pharmaceutical Products, 2nd Edition, 2021

2. Specialized GMP Areas – Audit experience in sterile products, APIs, biologicals, and/or medical devices.

3. Regulatory/International Organization Work – Prior auditing experience for or with WHO Prequalification, UN agencies, stringent regulatory authorities (SRAs), or national regulatory bodies.

4. Certification/Training – Holding relevant auditor certifications (e.g., GMP-specific audit training and/or ISO 9001 Lead Auditor, ISO 13485 Lead Auditor).

SUBMISSION REQUIREMENTS

Applicants must ensure their CV includes the following information at a minimum:

1. Academic qualifications (degree, institution, year of graduation, higher qualifications, if applicable).

2. Summary of GMP audits conducted in the last 5 years, indicating:

a) The year

b) Facility type (e.g., API, FPP, sterile injectables, biologicals, etc.)

c) Scope of audit

d) GMP standard applied (WHO TRS, PPB, EAC, EU, PIC/S, etc.)

e) Role (Lead/Team auditor)

3. Contact details of at least two professional references.

APPLICATION PROCESS

Interested and qualified applicants are invited to submit their CVs and supporting documents by Tuesday, 16th September 2025.

Only short-listed candidates will be contacted.