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South Africa: QC Compliance Officer

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Job Description

Requirements: Grade 12 BSC Microbiology (preferred) BSC Honours (preferred) If no work experience- BSC Honours If no honours qualification – 2 Years QA/QC Administrational job in the Pharmaceutical industry.or Document Controller 2 Years experience or Administration or Secretarial College and Computer skills- 2 years. Good documentation and organizational skills Communications with external and internal customers Good computer skills i.e., excel, word and PowerPoint Ability to work cross functionally with the external and internal customers Job Duties: Control of Laboratory documentation Control of laboratory samples Control of stability program Ensure quality compliance Registration of incoming samples (raw and pack mats, stability, bulk and PIT) in the QC Service Level Issue Test materials and LAFs to lab for testing Maintain Laboratory Analytical Form in line with latest pharmacopeia Order pharmacopeia on annual basis Trend lab data Compile COAs internal and external Perform annual review of pharmacopeia methods and update accordingly Ensure regulatory guidelines are kept up to date Ensure lab processes and systems are kept in line with latest guidelines and internal SOPs Maintain retention samples of tested raw materials and bulk in accordance with QC policy Ensure QC compliance: Change controls, Deviations, OOS, Training, SOPs, CAPAs Ensure SOP updates and alert 3-month prior on expired SOP(s) Manage archiving system for QC documents; maintain the archived documents with Metrofiles Ensure testing with 3rd party laboratories Request quotations for external testing and send samples. Perform internal self-inspections and monthly PCDA checks- ensure QC compliance Audit third party laboratories and vendors Assist with external audits Manage audit findings Administer and maintain stability program Maintain documentation in lab Report monthly KPI% on stability samples and other functions Maintain training program Ensure SLA with other departments are maintained Ensure SLAs with external vendors and labs are maintained Salary: Basic of: R18 000 – R25 000(Based on your experience) How to apply:
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