Oximio is a global pharmaceutical and healthcare logistics company supporting the safe and compliant movement and management of clinical trial supplies across international markets. We are looking for an experienced and highly motivated Deputy Pharmacist to join our team in Nairobi, Kenya. This is an exciting opportunity for a pharmacist who is passionate about clinical trial supply, pharmaceutical quality, regulatory compliance and patient safety and who thrives in a highly regulated, quality-driven environment.
The Deputy Pharmacist will support the effective and compliant operation of Oximio’s clinical trial supply chain and local warehouse operations, ensuring alignment with Good Practices (GxP), ISO 9001:2015, Kenyan legislation, Pharmacy and Poisons Board (PPB) requirements, Client requirements and Oximio procedures.The role provides professional and regulatory oversight across the medicinal product lifecycle, including receipt, storage, handling, labelling, distribution, returns and disposition, while ensuring product quality, traceability, accountability and appropriate storage conditions are maintained.
Regulatory & GxP Compliance
- Ensure clinical trial supply and warehouse activities comply with applicable GxP requirements, PPB requirements, Kenyan legislation, ISO 9001:2015, Client requirements and Oximio procedures.
- Provide professional and regulatory oversight of pharmaceutical and clinical trials supply activities.
- Support regulatory applications, notifications and other activities with the PPB and relevant authorities.
Clinical Trial Supply & Warehouse Operations
- Supervise and participate in the receipt, storage, inventory management, labelling/re-labelling, picking, dispatch, return and destruction of medicinal products and clinical trial materials.
- Ensure appropriate handling of packaging systems, data loggers and associated clinical trial materials.
- Maintain appropriate product accountability and traceability throughout the warehouse lifecycle.
Product Quality & Accountability
- Monitor product quality, inventory accuracy, expiry management and storage conditions.
- Review temperature monitoring data and support the investigation and management of storage deviations.
- Ensure appropriate documentation and reconciliation of clinical trial supply activities.
Quality Management System
- Support the implementation and continual improvement of the Quality Management System.
- Review and approve relevant quality documents, SOPs, Working Instructions and Standard Forms within delegated responsibilities.
- Maintain appropriate training and quality records.
- Support the investigation and resolution of quality-related issues.
Audits, Inspections & CAPA
- Support internal and external audits, Client audits and regulatory inspections.
- Maintain inspection readiness and ensure relevant documentation is readily available.
- Participate in investigations, root cause analysis, risk assessments and CAPA implementation and closure.
Product Recall & Quality Defects
- Coordinate product recall and quality defect activities.
- Liaise with clients, suppliers, internal stakeholders and regulatory authorities as required.
- Conduct periodic mock recalls to assess the effectiveness of recall processes.
Regulatory & Product Disposition
- Coordinate regulatory requirements relating to the importation, distribution, quarantine, return, recall and destruction of medicinal products.
- Ensure appropriate regulatory and quality documentation is maintained throughout the product lifecycle.
Pharmacovigilance
- Act as a back-up Qualified Person for Pharmacovigilance (QPPV) within delegated responsibilities.
- Support the maintenance and oversight of the pharmacovigilance system.
- Support the collection, evaluation, documentation and reporting of adverse events in accordance with applicable requirements.
- Develop and review new or revised Standard Operating Procedures (SOPs) and Work Instructions (WIs) within the scope of warehouse operations, product regulation and pharmacovigilance
Procurement & Supply Support
- Support procurement, comparator sourcing and material purchasing activities.
- Ensure purchased and received materials meet applicable Client and company requirements.
- Ensure appropriate quality documentation and certificates are available and maintained.
Environmental & Facility Compliance
- Support compliance with applicable environmental legislation and Oximio’s Environmental Management System.
- Support the appropriate management of environmental and product-related spills, including containment, reporting and corrective actions.
- Support compliant management and disposal of expired or damaged products.
- Report environmental incidents, risks, non-conformities and opportunities for continual improvement.
Requirements
- Bachelor’s Degree in Pharmacy (B. Pharm) or equivalent pharmaceutical qualification.
- Registered as a Pharmacist with the Pharmacy and Poisons Board (PPB)
- Minimum of 4 to 5 years’ relevant experience working in a regulated pharmaceutical, clinical research, healthcare or pharmaceutical logistics environment.
- Sound understanding of Kenyan pharmaceutical legislation, regulations, and guidelines governing pharmacy and healthcare operations.
- Comprehensive knowledge of GxP requirements, Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), and applicable quality standards.
- Up-to-date knowledge of healthcare legislation and regulatory requirements issued by relevant health authorities and governing bodies.
- Proficient in Microsoft Office applications and other computerized pharmacy and warehouse management systems.
- Strong financial acumen with the ability to interpret, analyze, and report on operational and financial data.
- Excellent leadership, stakeholder management, communication, planning, and problem-solving skills.
- Strong attention to detail and commitment to maintaining the highest standards of quality and regulatory compliance.
- Demonstrated ability to work independently, make sound decisions, and manage multiple priorities in a regulated environment.
- Continuous-learning mindset with a commitment to professional development and staying current with industry best practices.
Benefits
- A strategic, high-impact role in a growing international organisation.
- A collaborative, global team environment.
- Professional development opportunities in an international environment.
- A collaborative, supportive, and purpose-driven working environment