Production Technician N.C.A(Hay Level 13/C2) at NECSA

PRINCIPAL ACCOUNTABILITIES

SAFETY

• Ensure compliance to facility license and all production requirements.
• Ensure compliance to safety and the use of PPE.
• Ensure that Production processes are safely executed.
• Participate in SHEQ audits.
• Participate in safety events investigations and closed out effectively within target dates.
• Assist NTP in achieving its overall SHE targets.
• Ensure that safety objectives are achieved (No Safety event)
• Ensure the safe & compliant operation of Lu-177n.c. a Facility and safety of personnel optimised.

QUALITY 

• Ensure that cGMP and GDocP requirements are complied with.
• Ensure that all SOPs and other documents needed for Lu-177 operational activities are available at a plant and kept current, and that activities are conducted in compliance to the SOPs.
• Ensure that work is done in accordance with relevant procedures, and that relevant quality records are generated (e.g., current LOT’s, current forms etc.)
• Review generated records and ensure that they comply to GDocP requirements.
• Ensure that the necessary documentation is always available at the workstation.
• Ensure that qualified and calibration equipment’s are used in the production process.
• Ensure the daily verifications of pH Meters, ionisation chambers and balances are conducted, and that relevant Logbooks are completed, and records are generated.
• Participate in audit findings investigations and assist in closing the actions on target dates as agreed to with relevant stakeholders.
• Ensure that overall quality objectives are achieved.
• Ensure that internal and external customers are satisfied.
• Ensure that the consumables stock levels are kept at acceptable status to avoid shortages at all times.
• Report stock levels, issue stock and communicates to the production manager/ production engineer when re-order levels are reached.
• Ensure that customers get their orders/requests on time and within specifications.
• Assist in keeping NTP’s customers satisfied and happy.
• Ensure Compliance to data integrity.

SUSTAINABLE, EFFICIENT PRODUCTION AND SUPPLY OF APIs 

• Complete all batch production records at the time of executing tasks as per GDocP.
• Ensure all microbiological monitoring is completed and submitted after clearance from controlled areas.
• Submit QC samples to relevant laboratories in accordance with SOP.
• Perform preparation of production system, reagent cabinet, waste cabinet, LAF, dispensing system, hot cells and autoclave according to procedure.
• Return material from QC laboratories in accordance with SOP
• Submit decayed microbiological samples to the QC department
• Produce all batches of Lu-177 n.c.a within specifications (compliance on RCP, RNP, pH, appearance, activity concentration)
• Manually operate the dispensing system in accordance with SOP when necessary.
• Assist with qualifications and product stability studies according to procedure and relevant protocols.
• Qualify autoclave and hot cell equipment with service providers in accordance with procedure
• Assist with production system replacement schedules including column manufacturing, regenerating, system line, valve block and crusher tube replacements.
• Monitor process parameters and report deviations to production manager
• Ensure the production of Lu-177 n.c.a in compliance with the DMF, procedures and customer specifications.
• Ensure that customer orders are dispensed accurately and meets the internal cut-off times
• Participate in any Lu-177.nc.a production troubleshooting (Engineering applications)
• Ensure that post-production clean up steps are executed, and evidence thereof is available.
• Always participate in effective communication.
• Ensure compliance to NTP values and business objectives.
• Ensure that Lu-177 n.c.a Production Efficiency Metrics Targets Achievement (Yields target, sold Vs produced)
• Comply to all company policies e.g. leave, overtime, IT etc.
• Review and update documents as is necessary
• Generate new documents when there is a new process
• Ensure that your training is up to date at all time
• Participates in deviations and CAPAs investigations.
• Co-ordinate and plan validation processes and batches

WASTE MANAGEMENT 

• Segregate nuclear waste in accordance with procedure.
• perform waste removal in accordance with procedure and in the presence of an RPO.
• Ensure that Lu-177 n.c.a production line is kept in a good housekeeping state as per requirements for API production.
• Ensure that waste in the hot cells is kept as minimum as possible.
• Ensure compliance to liquid waste management processes. (Liquid waste tank status current and accurate and files updated accurately)
• Ensure compliance to solid waste management processes.

QUALIFICATIONS AND EXPERIENCE

• National Diploma Chemical Engineering, Analytical Chemistry, Chemistry, Physics or equivalent.
• Experience in Radiopharmaceutical\ Radiochemical Production Environment is required.
• Knowledge of cGMP, GDocP and ISO9001:2015 audits would be advantageous.
• At least 12 months in Production experience having served in a Radiopharmaceutical\ Radiochemical or similar production environment.