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

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