- 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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Group Loss Control Officer
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Quality Control Officer - Centurion, South Africa - JoburgJobs
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
Testing
Equipment
QC
Training
Requirements