Quality Control Officer

• 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

• 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.

• 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.

• 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.

• 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.

• 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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