Officer, Validation, Contract Logistics

Main Purpose of the Role  

• To plan, execute and maintain vehicle qualification and transport lane risk assessments for healthcare distribution. The role ensures that transport solutions remain suitable for their intended use through risk-based validation, temperature monitoring, data analysis and controlled reporting.

Qualifications  

• Essential: Matric.
• Advantageous: A diploma or degree in Quality Assurance, Engineering, Logistics, Pharmaceutical Sciences or a related scientific field.
• Relevant validation, cold chain or quality management training is advantageous.
• Computer Literacy Level 
• Advanced Microsoft Word and Excel skills for technical reporting, data analysis and maintenance of validation registers.
• Proficient in Microsoft Outlook and PowerPoint.
• Additional Computer Skills  
• Ability to configure temperature data loggers, download results and use temperature monitoring software.
• Experience with electronic quality management systems, document control platforms and data trending tools is advantageous.

Job Related Requirements  

• Minimum three years’ relevant experience in validation or qualification within pharmaceutical, healthcare or other regulated environments.
• Practical experience compiling and executing validation protocols, risk assessments and technical reports.
• Working knowledge of Good Distribution Practice, Good Warehousing Practice and temperature-controlled distribution.
• Ability to interpret temperature data, investigate discrepancies and draw evidence-based conclusions.
• Strong technical writing, analytical, organisational and stakeholder coordination skills.
• Ability to manage concurrent studies and independently take ownership of assigned validation activities.
• Valid driver’s licence and willingness to travel to operational sites and support scheduled studies outside normal working hours when required.

Added Advantages for the Role  

• Experience in vehicle temperature mapping, transport qualification or transport lane risk assessments.
• GMP experience and exposure to broader equipment, facility or process validation.
• Experience supporting audits, deviation investigations, CAPAs and change control.
• Knowledge of calibration traceability and the suitability of temperature monitoring equipment.

Duties & Responsibilities  

• Plan and execute vehicle qualification, requalification and periodic reviews.
• Maintain the Vehicle Validation Master Plan and associated qualification schedules and registers.
• Prepare and maintain validation plans, risk assessments, applicable DQ/IQ/OQ/PQ protocols, traceability matrices and reports.
• Coordinate and execute local and export transport lane risk assessments, including seasonal monitoring activities.
• Define study requirements, logger placement, sampling strategies and acceptance criteria based on documented risks and intended operating conditions.
• Coordinate vehicle availability, study loads, logger deployment and data retrieval with Operations and relevant stakeholders.
• Verify that monitoring equipment is calibrated and suitable for the intended studies.
• Analyse temperature data, assess excursions and compile reports with clear conclusions and recommendations.
• Assess changes to vehicles, routes and distribution processes for validation impact.
• Investigate deviations and support CAPAs, effectiveness checks and audit responses.
• Maintain controlled records, SOPs and work instructions to support audit readiness and data integrity.
• Provide operational training and guidance on qualified transport conditions and monitoring requirements.
• Report progress, overdue activities and significant risks to the Validation and Accreditation Manager.
• Support other departmental validation activities as assigned.