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Centurion

    Quality Control Officer - Centurion, South Africa - JoburgJobs

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    Full time
    Description

    As a Quality Control Officer, you will be responsible for ensuring that our products meet the established quality standards before they reach the customers. You will play a critical role in maintaining and improving our quality assurance processes.

    Duties & Responsibilities:

    Documentation

    • Review and complete Sampling Specifications and Master Release Specifications
    • Create, review and update BMRs and BPRs
    • Review complete and prepare Batch Release Documentation for Finished Products
    • Write, develop, and update Standard Operating Procedures in accordance with PIC/S and SAHPRA Guidelines
    • Issue certified copies of Failure investigation, Deviations, CAPA and Change Control report
    • Complete Master Release Specifications for Finished Products
    • Print, create and prepare logbooks for issuing
    • Maintain the logbooks issuing, return and archiving spreadsheet
    • Prepare and Print Status Labels for incoming materials (Quarantine, Sampling & Release) and all other status labels used in production
    • Ensure all documents adheres to Good Documentation Practices and Data Integrity Principles
    • Maintain Training Attendance Registers and Evaluated Training Records for all staff
    • Maintain the Key and Access Register in Quality Assurance
    • Filing of Attendance Registers and Evaluated Training Records for all Staff

    Testing

    • Conduct testing of sampled raw materials using the moisture analyser and disintegration tester
    • Conduct testing of In-Process and Finished Product for release
    • Conduct Visual Checks on sample Raw Materials, In-Process Product and Finished Product
    • Conduct Laboratory Testing Activities in accordance with Good Laboratory Practices, Good Documentation Practices and Good Manufacturing Practices
    • Operate Testing Equipment in accordance with approved Standard Operating Procedures.
    • Basic Cleaning of Laboratory Bench Tops and Testing Stations.

    Equipment

    • Ensure all testing and measurement equipment verification and calibration status is valid.
    • Maintain Updated Records for Calibrations Certificates of Magnehelic Gauges, Data Doggers, Scales, Balances, Weights, Vernier callipers, Moisture Analyzer and Disintegration Tester.
    • Preventative Maintenance of Testing and Measuring Equipment
    • General Maintenance and Cleaning of Laboratory Glassware and DIT Baskets, Beaker Stand, Water Bath and Perforated discs.

    QC

    • Ensure that SGWH, Production and Quality department processes adhere to Standard Operating Procedures, PIC/S and SAHPRA Guideline and the organization's Pharmaceutical Quality Management Systems.
    • Conduct Internal GMP Compliance Surveillance and Internal Audits
    • Perform Daily In-Process Quality Checks
    • Perform Verification Checks and Accuracy of Weighed or Dispensed Raw Materials
    • Ensure Environmental Monitoring Devices are Operational and Data is Downloaded from Loggers every Month.
    • Execute Deviations, CAPAs, Investigations and Change Controls according to approved procedure.
    • Participate in Quality Investigations.
    • Conduct Routine Compliance Checks.

    Training

    • Development, Implementation and Management of a Competency Based Training Programme
    • Conduct Induction Training for New Recruits in accordance with the Training Procedures
    • Schedule internal and external training for all staff
    • Prepare and Conduct Training according to Schedules and Plan
    • Update Training Schedule and Plan to be in line with production requirements
    • Update Training Spreadsheet and Training Matrix
    • Evaluate Competency Assessments
    • Report on the outcomes of the assessments to Supervisors, Managers and Responsible Pharmacists
    • Maintain Training Session Treats Stock
    • Maintain applicable administration procedures, policies, and reports to ensure compliance with process and regulatory requirements.
    • Promote and execute the Quality Policy throughout the organization.
    • Promote cGMP Training throughout the organization.
    • Participate in Quality and GMP initiatives.

    Requirements

    • A degree in a BSC or related field
    • Proven experience in quality control, quality assurance, or a similar role within a manufacturing or production environment
    • Attention to detail and a commitment to maintaining high standards of quality and integrity
    • Ability to work independently, prioritize tasks, and manage multiple projects simultaneously


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