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.