Laboratory Technician at NECSA

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.