speranza Njeri

Supported establishment and operationalization of a PPB‑compliant oral pharmaceutical manufacturing facility, developed SOPs and QA systems, and led equipment qualification and GMP readiness to ensure product quality and regulatory compliance.

Ensured regulatory compliance and maintained pharmaceutical quality systems, directed Annual Product Quality Reviews, oversaw in‑process and finished product testing, and implemented corrective actions to uphold product standards.

Supported clinical pharmacy services including medication review, adverse event reporting to PPB PvERS, ward rounds participation, and extemporaneous preparations to improve patient safety and medication use.

Managed QA documentation (BMRs, BPRs, QC reports), reviewed test data for quality issues, and implemented process improvements that reduced QA test time by 74%.

Attended an introduction to pharmacovigilance course to build competencies in drug safety monitoring.

Completed a Bachelor of Pharmacy program focused on pharmaceutical sciences, dispensing, and clinical pharmacy practice.

Completed a postgraduate diploma covering regulatory affairs, pharmacy administration, and pharmacy policy with emphasis on pharmaceutical regulation and quality systems.

Undertook training in good governance for medicines and ethics in procurement related to pharmaceutical governance.

Completed training in pharmacovigilance focusing on drug-induced liver injury and adverse event monitoring.

Completed professional credential courses including Good Clinical Practice, Leadership and Management in Health, and Responsible Conduct of Research.