Quality Assurance Pharmacist

2 weeks ago

Johannesburg, Gauteng, South Africa Qetello Holdings Full time

Duties and Responsibilities:

Responsible for compliance with legislation in terms of:

  • GMP/GWP/GDP compliance
  • Accurate record keeping
  • Selfinspections
  • SOP compliance and review
  • Manufacturer/packer/lab audits
  • Contracts with third parties
  • 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 the stock destruction certificates.
  • Customer QC Control on finance new accounts opened

Manages the Quality Standards with regard to:

  • 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 approvals
  • 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

Responsible for system implementation:

  • 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:

Years' experience as a QA Pharmacist

  • BPharm Degree

Skills and Competencies:

  • Intermediate understanding of Microsoft Office (Excel, Word, Powerpoint and Outlook).
  • High integrity and honesty and are bound by ethical principles.
  • Resilient, does not give up in the face of setbacks.
  • Attention to detail
  • Accuracy
  • Analytical
  • Time management skills
  • Good communication skills.
  • Deadline driven
  • Ability to resolve conflict
  • Team player
  • Good problemsolving skills
  • Persistence
  • Good organisational skills
  • Good planning skills.
  • Good followup skills.

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