Vacant Opportunities 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.

go to method of application »

Key Performance Areas:

PRODUCT RELEASE:

• Control the manufacture, sale and distribution of products
• Ensure quality standards, processes and specifications align to cGMP requirements
• Ensure production activities and personnel comply with cGMP and relevant standards and guidelines
• Manage and control the process of quarantine, sampling, release of intermediates and finished products
• Oversee batch review and final accountability for release of raw materials, packaging materials and finished products
• Ensure appropriate storage and storage conditions for materials and products
• Act as custodian of retention samples as representative samples of batches sold

LEGAL AND REGULATORY COMPLIANCE

• Manage licensing requirements as per DoH, SAHPRA and SAPC requirements.
• Advise NTP on the impact of new legislation on current business.
• Ensure that marketing/sales activities are compliant with the various laws and codes.
• Review and approve promotional materials to ensure compliance with local regulatory/ legal requirements.
• Manage the control and sale of medicines.
• Oversee dossier management/maintenance and submissions to the authorities.
• Ensure timely payments of relevant annual fees for the pharmacy, products and pharmacists.
• Serve as member of the Change Control Committee.

PRODUCT AND PROCESS PERFORMANCE

• Ensure GMP guidelines are introduced into the facility processes to comply with regulatory requirements.
• Ensure implementation and maintenance of comprehensive pharmaceutical quality systems (PQS) and quality management systems (QMS) in the facility. 
• Oversee the evaluation of batch records and the final release of the product.
• Oversee self-inspections, audits and compilation of audit reports with corrective and preventative actions to expedite timely closure.
• Review annual quality product reviews.
• Review the trend analysis for key quality parameters.
• Manage the deviation and CAPA processes in the facility.
• Ensure all customer complaints are recorded, investigated and CAPAs put in place and that customers are given feedback relating to the investigations.
• Oversee the change control system in the facility.
• Manage the product recall process and conduct mock recalls.
• Manage all contractors and suppliers of materials and services through establishment of agreements.
• Provide guidance on compliance matters to personnel.
• Enforce integrity of behaviour of NTP personnel by reporting non-compliances.
• Maintain specified environmental controls for manufacturing of products.
• Act as pharmacovigilance officer for the site (for NTP and imported products)
• Maintain a stability program for manufactured products.

SOP AND DOCUMENTATION MANAGEMENT

• Ensure only personnel with appropriate knowledge and experience are appointed in key positions.
• Prepare, update, review and approve facility SOPs, reports and documents.
• Ensure facility documents are current.
• Ensures the facility is compliant to cGMP requirements.
• Ensure effective training of personnel in GMP, relevant guidelines and topics with associated training records.
• Review new guidelines, external inspection reports and current trends to keep site inspection ready.
• Ensure calibration status of equipment and instruments is current.
• Establish and maintain a master validation plan.

Requirements

Minimum Qualifications and Experience:

• B.Pharm degree or equivalent.
• Registered as a pharmacist with SAPC.
• 8 years in a Pharmaceutical Manufacturing Industry (with experience in Production and Quality Assurance)
• 4 years Management experience is essential.
• Experience as Responsible Pharmacist.
• Pharmacovigilance experience.