Job Description

Key Performance Areas

Co-ordinate activities relating to the production of Mo-99 and I-131 in compliance with the DMF, procedures and customer specificationsCo-ordinate and compile daily, weekly, monthly and annual API (Mo-99 and I-131) production plans and reportsEnsure that the target plates for Mo-99 production are available for productionCo-ordinate and verify the selected columns to be processed for each I-131 batchLiaise with Marketing and Sales for the sales plan and contracting thereof, as well as the status of product availabilityEnsure that all batches produced are within specifications (compliance on RCP, RNP, pH, appearance, activity concentration)Ensure that customer orders are dispensed accurately, and meets the internal cut-off times specified on the ODMSEnsure that deviations and CAPA’s are managed as per procedure and are minimisedEnsure that events are closed as required by relevant proceduresCo-ordinate all I-131 and Mo-99 production troubleshootingGenerate product predictions prior to monthly productionEnsure that post-production clean up steps are executed, and evidence thereof is availableEncourage continuous improvement at all timesOversee critical Mo-99 and I-131 production activitiesContribute to Change Control Notice (CCN) and Nuclear Facility (NFSC)

 

Ensure compliance to cGMP and GDP requirements:

Ensure that all documents (Proper training required with a test), get qualified, and co-ordinate to ensure that all requirements relevant to RAD Production are adhered to. Keep the evidence of complianceEnsure that all SOPs and other documents needed for RAD operational activities are available and kept currentEnsure that work is done in accordance with relevant procedures, and that relevant quality records are completed (e.g. route cards, forms etc.)Review generated records and ensure that they comply to GDP requirementsEnsure that critical equipment is identified, validated and that their calibration status is kept currentManage the daily and monthly verification's of ionisation chambers, balances, and that relevant records are generated;Ensure that personnel are adequately trained and authorised, (practical and theoretical training, including certification) and that their training records are kept currentEnsure that audit actions are closed out effectively on target dates as agreed to with relevant stakeholdersEnsure that overall quality objectives are met as per NTP Quality Policy

 

Ensure internal and external customer satisfaction:

Ensure that the dispensed production consumables function according to expectation (e.g. No leaking pipes/tubing, no foreign substances in dispensed consumables, etc.)Ensure that the correct consumables for dispensing customer’s orders are requested at all timesEnsure that customers get their orders/requests on time and within specifications

 

Ensure that SHEQ goals are achieved:

Ensure compliance to facility license requirements and Operating Technical Specification (OTS) (Training required on the system)Ensure employee compliance to safety and the use of PPEMaintain radiation worker’s status in RAD Production (by ensuring that they write and pass radiation worker exams, attend whole body counts, attend statutory training and attend all compulsory safety presentations)Ensure that SHEQ processes are maintained and that related audits are successfulEnsure that safety events are investigated and closed out effectively within target datesAssist NTP in achieving its overall SHEQ targetEnsure compliance to overall safety as per Safety Policy Statement

 

Planning and Leadership Activities:

Ensure proper planning for the smooth running of production activitiesProcure the IN-CELL equipment and accessories as needed in order to maintain productionDetermine the staff requirements, permanent and contractors, in accordance with the expected deliverables

 

Conduct performance planning and compile the performance management documentation in collaboration with the staff member in terms of:

Personal Development PlanContinuously provide feedback and coaching to manage that the staff member/s performs at optimum productivity levelConduct performance reviews in accordance to the policies and procedures and take corrective actions where necessary;Exposure to cGMP, GDP and ISO9001:2015 audits would be advantageousExposure to Change Management, and basic understanding of acts, such as BCEA, EEA, OHSA, etc.Proven track record of managing a plantReport writing capabilitiesMust portray leadership skills and be a team player