Job Description

Job purpose:

NTP has a vacancy for a Lu-177 n.c.a Production Technician. The incumbent will be responsible for:



safe operation in the production of Lu-177 n.c.a products and supplying customers with Lu-177 n.c.a products in compliance to Customer specifications, just in time (JIT) delivery, radiochemical purity, radionuclidic purity, activity concentration, and other product related specifications.



The Lu-177 n.c.a Production Technician is also responsible for ensuring that the Lu-177 n.c.a Production unit operations are carried out successfully through Engineering and Chemistry applications, complies with laws of the country, facility nuclear license, applicable cGMP requirements, NNR operational conditions and Necsa Group's applicable policies.

KEY PERFORMANCE AREAS

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.

KNOWLEDGE AND SKILLS

A strong cGMP background Basic knowledge and understanding Production in a RadiopharmaceuticalRadiochemical environment. A strong background working in a production environment/ plant. Knowledge and understanding of the company policies and procedures applicable to the specific work environment to ensure that work outcomes are compliant to the policies and procedures. Knowledge of Safety in a Radiopharmaceutical manufacturing facility.

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.

OTHER SPECIAL REQUIREMENTS

Registered as a Chemicals Worker Registered as a Radiation worker Be prepared to work shifts Be able to work under pressure and be prepared to work irregular hours.

Closing date: 14 May 2025

CONTACT PERSON

Ms. Joy Tsoku

Tel: 012 305 4342/ joy.tsoku@ntp.co.za

Please forward your updated CV with certified copies of your educational qualifications to https://necsa.mcidirecthire.com/Internal/CurrentOpportunities. Please ensure that you quote the correct Job Reference number on the subject line of your email application. Applications received with an incorrect Job Reference number shall not be considered, as the automatic sorting system will not be able to recognize them.

Necsa Group is committed to Employment Equity when recruiting. Therefore, priority will be given to African Females, African Males, and people with disabilities, in support of achieving our Employment Equity targets.

Should you not hear from us within 30 days of the closing date, please consider your application unsuccessful.