Job Vacancies at NECSA

Business Units Risk Governance:

• Embed Risk Management practices in Necsa, monitoring and reporting on the risks identified.
• Develop strategic policies related to risk management.
• Provide advice and support to the customers of the department.
• Manage the Risk Management System.
• Represent Necsa in all the relevant Risk Management structures and committees
• Review and update the risk management framework, policy, strategy and procedures as required.
• Manage the Review Panel and action or follow up on items raised.
• Assist with the maintenance and review of Necsa Risk Register incorporating Necsa’s strategic, project and operational risks.

Risk Monitoring

• Devise risk mitigation strategies with line management and ensuring follow through on implementation of these.
• Coordinate management of risk across Necsa to eliminate or minimise risk exposure, including review of controls and actions.

Risk Management Awareness

• Provide training and advice to management and staff to assist them to manage risk.
• Ensure awareness of Necsa’s Fraud & Corruption Control Policy and Fraud Control Plan, and contribute to their review and update

Fraud Risk Management

• Assist management to identify fraud risks and follow through on the implementation of mitigations
• Assist to oversee the fraud hotline  and the timely reporting

Combined Assurance

• Assist to put in place systems to implement the combined assurance model for Necsa
• Support the implementation of combined assurance process and report timeously to the relevant structures.

Risk Reporting

Prepare and submit risk management reports for:

• DMRE report
• Audit & Risk Committee Report
• EXCO Risk Management Committee report

Minimum Qualifications and Experience:

• B Degree Internal Audit/Risk Management and or other relevant three year tertiary qualification
• Internal Audit or Risk Management related accreditation.
• Honours Degree Internal Audit/Risk Management will be an added advantage
• 5-10 years Risk Management/ Internal Auditing in a large organisation with at least 3 years in a management position

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PRINCIPAL ACCOUNTABILITIES

GENERAL AND TASK MANAGEMENT

• To perform all manufacturing of reagents and preparation for other productions.
• Ensure that cGMP and GDocP (Good document practice) requirements are met, regarding procedures and sterility for radiopharmaceuticals.
• Ensure quality products are manufactured (properly documented through calculations and signatures), within spec, safe, and reliably according to SOP’s.
• Knowledge of instruments used in the production laboratories.
• Basic knowledge of computer skills for record keeping.

TECHNICAL ASPECTS

• Ensure all reagent batch records are ordered, completed, and transferred between the relevant buildings to ensure proper document control, GDocP and quality requirements and in accordance with SOP.
• Complete all logs contemptuously in accordance with SOP.
• Ensure all reagents are sufficient and released according to SOP in time for final production of Lu-177 n.c.a products.
• Ensure microbiological monitoring is logged and completed in accordance with SOP and environmental and instrument parameters are recorded and logged according to SOP.
• Ensure microbiological monitoring consumables are submitted for analysis.
• Report any deviations or changes to the production manager.
• Prepare and submit all filled Yb-176 ampoules in accordance with procedure.
• Store consumables in dedicated areas as per SOP.
• Ensure accurate calculations of all laboratory reagents and consumables needed for final product manufacturing in accordance with cGMP requirements.
• Ensure accurate capturing and record keeping of production related data in accordance with cGMP requirements.
• Ensure accurate labelling, packaging, and dispatch of all intermediate and final products in a cGMP compliant manner.

QUALIFICATIONS AND EXPERIENCE

• Post Basic pharmacist Assistant or /National Diploma in Analytical Chemistry or equivalent.
• cGMP and GDocP Training must be current.
• B.Sc./B. Tech in Chemistry/ Analytical as majors will be advantageous.
• Preferably, a minimum of 12 months in relevant working experience in a Production environment.
• Exposure to cGMP regulations
• Must be medically fit to qualify as a radiation and chemical worker.
• Must be capable of working under limited supervision.
• Self-motivated, willing to learn beyond laboratory activities.