Quality Control Technician (Hay Level 12/C1) (5 Posts) (Internal & External) at NECSA

KEY PERFORMANCE AREAS

PRINCIPAL ACCOUNTABILITIES

GENERAL AND TASK MANAGEMENT

• Implementing and maintaining GLP (Good laboratory practice).
• Maintaining safety and general housekeeping of the laboratories in use.
• Optimize and facilitate implementation of current processes.
• Propose changes or improvements to processes, and techniques.
• Prepare and analyze samples according to standard operating procedures.
• Prepare and operate and maintain laboratory equipment according to standard operating procedures.
• Perform calibration checks on equipment according to calibration procedure, to ensure accurate results and assist in sending out equipment for calibration and necessary maintenance.
• Prepare reagents and solutions for testing.
• Performing quality checks / analytical tests on raw materials, intermediate and final products.
• Experienced in the use of automatic titrators, pH and conductivity meters, IC, HPLC, GC, UV-VIS spectrophotometer, and general laboratory equipment.
• Perform routine analysis on in-process and final products, raw materials and components.
• Support testing for OOS investigations
• Handle problems efficiently according to quality policy.
• Report feedback on services or outputs regularly to customers.
• Check HPLC/GC runs regularly during the early morning shift.
• Provide internal customers with accurate test results.
• Propose, develop and update methods for improving customer service.
• Check, document and report operational output against actuals.
• Communicate deviations for production and process improvements.
• Must have sufficient current knowledge of the method used, as well as the objectives of the test.
• Document and store data according to standard operating procedures and regulations.
• Must be conversant with the management system implemented within the organization, ensuring that all results are reported accurately, unambiguously, and objectively.
• Record, interpret and report testing results to management, including OOS results, Deviations other quality issues as needed.
• Participate in OOS Investigations, Deviations and CAPA’s, and ensure action taken is appropriate.
• Utilize the LIMS system to full capacity.
• Must be able to assess and interpret the data.

TEST PREPARATION

• Prepare and analyze samples according to standard operating procedures.
• Prepare and operate and maintain laboratory equipment according to standard operating procedures.
• Perform calibration checks on equipment according to calibration procedure, to ensure accurate results and assist in sending out equipment for calibration and necessary maintenance.
• Prepare reagents and solutions for testing.

TESTING

• Performing quality checks / analytical tests on raw materials, intermediate and final products.
• Experienced in the use of automatic titrators, pH and conductivity meters, IC, HPLC, GC, UV-VIS spectrophotometer, and general laboratory equipment.
• Perform routine analysis on in-process and final products, raw materials and components.
• Support testing for OOS investigations
• Handle problems efficiently according to quality policy.
• Report feedback on services or outputs regularly to customers.
• Check HPLC/GC runs regularly during the early morning shift.
• Provide internal customers with accurate test results.
• Propose, develop and update methods for improving customer service.
• Check, document and report operational output against actuals.
• Communicate deviations for production and process improvements.

REPORTING AND RECORD-KEEPING

• Must have sufficient current knowledge of the method used, as well as the objectives of the test.
• Document and store data according to standard operating procedures and regulations.
• Must be conversant with the management system implemented within the organization, ensuring that all results are reported accurately, unambiguously, and objectively.
• Record, interpret and report testing results to management, including OOS results, Deviations other quality issues as needed.
• Participate in OOS Investigations, Deviations and CAPA’s, and ensure action taken is appropriate.
• Utilize the LIMS system to full capacity.
• Must be able to assess and interpret the data.

TECHNICAL ASPECTS

• Ensure all glassware, apparatus/utensils, equipment, instruments and work benches/basins are clean, neat and in good working condition ready to be used.
• All reagents, supplies and other materials needed for work are available in storage cupboards/areas,
• SHEQ records/registers are up to date, quality control/assurance actions are done, your PPE and any other safety/environmental controls are in good working order and inform QC Manager of any deviation from normal conditions.

Requirements

Minimum Qualifications and Experience:

• National Diploma in Analytical Chemistry or equivalent.
• Minimum of 2 years Laboratory experience in a pharmaceutical laboratory.
• 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.