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Regional Quality Assurance and Regulatory Affairs Pharmacist with over 17 years of experience health products supply chain, quality management systems including ISO 9001, regulatory affairs and leadership. Seeking new opportunities. Willing to relocate from country of residence. |
 Contact Veronica Thuku
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Area of Expertise: |
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Capacity Building, Training, Advocacy
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Health, Doctors, Nurses, HIV/AIDS
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Monitoring, Evaluation, Policy, Research, Analysis
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Professional Experience: |
Regional Quality Assurance and Regulatory Affairs Pharmacist with over 17 years of experience in the development, implementation, monitoring, assessment, and strengthening of health products quality affairs, policies and strategies, quality management systems, procurement activities and risk management frameworks for healthcare products and technologies across Africa.
Proven ability to analyze and localize global and regional regulatory and quality processes to ensure compliance with organizational and country-specific requirements.
Stakeholder liaison, navigating complex regulatory frameworks with various stakeholders including governments, regulatory agencies, local health authorities, and non-profit partners to gain organizational accreditation as a Humanitarian Purchasing Centre and Local Distributor (from ECHO, OFDA and MSF), facilitate product registrations/re-registrations, distribution, and safety reporting.
Effective communicator, fluent in English and Kiswahili with advanced use of MS Office Suite; solid knowledge of Good Manufacturing Processes, Good Storage Practices, and Good Distribution Practices.
CORE COMPETENCIES
Quality Assurance (QA) | Quality Management Systems (QMS) Developer | Quality Audits Expert | Pharmacovigilance | Regulatory Affairs | Medical Governance & Compliance | Risk Management | Team Leadership | Budget Management | Stakeholder Collaboration | Training/Capacity Building | Supply Chain |Medical Safety & Regulations | Quality Policy & SOPs Development | Product Registrations & Renewals
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Education: |
1.PhD in Biotechnology & Regulatory Affairs – Purdue University, USA (August 2020 – August 2025)
2.Master of Science in Biotechnology & Regulatory Affairs – Purdue University, USA (March 2018 – May 2020)
3.Postgraduate Diploma in Industrial Pharmacy – Purdue University/ St. Luke Foundation/ Kilimanjaro School of Pharmacy, Tanzania (August 2010 – March 2012)
4.Diploma in Healthcare Management Level 1 – Kenya Institute of Management (April 2005 – September 2005)
5.Bachelor of Pharmacy – University of Nairobi (October 1999 – October 2003)
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Affiliations and Achievements: |
Deliverables:
? Supported two sites in Kenya and Nigeria in achieving 80% site compliance to in-country laws and regulations, organizational policies, and international standards (2017) as defined by WHO.
? Delivered 70% compliance rate in Juba, South Sudan- a first for the country.
? Improved GDP compliance in identified prioritized ICRC sites to 80%.
? Formalized an internal quality control process to verify alcohol-levels in locally sourced hand sanitizers.
? Developed and reviewed the quality policy, as well as purchasing, recruitment, cold chain handling, environmental, business contingency, goods return and product expiry policy.
? Improved audit program for the 80 suppliers by 120% and implemented an accountable supplier selection and product risk assessment systems.
? Introduced changes in temperature monitoring system with migration to a real-time data logger-based system, as well as use of transit temperature cold-chain monitoring.
Affiliations
Registered Pharmacist – Pharmacy and Poisons Board, Kenya
Member – Pharmaceutical Society of Kenya
Member – International Pharmaceutical Federation
Member – The Quality Assurance Group
Member – The Quality and Regulatory Network
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Available for: |
- Consulting assignments
- Job opportunities
- Being headhunted – make me an offer
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