Job Description

Key purpose:

To ensure that the Company complies with the Quality principles as set out by legislation of the Medicines Control Council (MCC) and the South African Pharmacy Council (SAPC) and to ensure products released by the company onto the market meet all quality specifications.

Duties and responsibilities:

• GMP/GWP/GDP compliance
• Accurate record keeping
• Self-inspections
• SOP compliance and review
• Manufacturer/packer/lab audits
• Technical agreement compilation, review and updates
• Distribution of agreements
• Investigation of technical complaints and trend analysis
• Annual product reviews (SOP, plan and review)
• Ensuring validity of customers and SOP update
• Disposal of expired or rejected stock and retention of stock destruction certificates.
• Customer QC Control on finance new accounts opened
• Regulatory applications including SAHPRA, DOH, SAPC
• Product sampling for re-testing
• Facilitate post importation testing
• Oversee standard levels at laboratory
• Batch documentation auditing, record and control
• Finished product release
• Ensure quality of products out in the market
• Storage and control of retention samples
• Submission of status reports
• Artwork/packaging review and approval
• To review and approve the validation reports
• Development control and approval of new product bar codes
• To review and approve master documentation
• Stability test results
• Managing schedule 6 registers
• Implementation and monitoring temperature on incoming shipments
• Documentation management and control
• Validation of stock control system to control authorised product release and automatic quarantine and release of stock
• Mock recall
• Quality Manual
• Risk Management
• SOP Review and updates
• Keep informed of changes in Regulations or legislative changes that will impact on the way Austell manages its quality systems
• Ensuring that quality systems are in place and are continuously updated to reflect current practice
• Ensuring that all information is readily available for audit purposes and that it is backed up

Qualifications and experience:

• BPharm Degree
• Minimum 2 years experience as a QA Pharmacist
• Intermediate understanding of Microsoft Office (Excel, Word, Power point
  and Outlook).
• Updated knowledge of MCC and SAPC legislation and guidelines
• Updated knowledge of pharmaceutical GMP/GWP/GDP/GLP