Jobs Career Advice Signup
X

Send this job to a friend

X

Did you notice an error or suspect this job is scam? Tell us.

  • Posted: Jan 16, 2025
    Deadline: Not specified
    • @gmail.com
    • @yahoo.com
    • @outlook.com
  • Never pay for any CBT, test or assessment as part of any recruitment process. When in doubt, contact us

    Mandate To develop, utilise and manage nuclear technology for national and regional socio-economic development through: Applied R&D; Commercial application of nuclear and associated technology; Contributing to the development of skills in science and technology.
    Read more about this company

     

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

    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 »

    Responsible Pharmacist (Hay Level 17/D2) (2Posts) (Internal & External)

    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.

    Method of Application

    Build your CV for free. Download in different templates.

  • Send your application

    View All Vacancies at NECSA Back To Home

Subscribe to Job Alert

 

Join our happy subscribers

 
 
Send your application through

GmailGmail YahoomailYahoomail