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QC Compliance Officer

QC Compliance Officer

Greys RecruitmentGermiston, Gauteng, South Africa
2 days ago
Job description

Overview

Our Client is seeking a QC Compliance Officer to join their company in Gauteng, Germiston

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

  • Follow the link to our jobseeker’s page-
  • Search for the job title.
  • Click Apply to submit your CV
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    Compliance Officer • Germiston, Gauteng, South Africa

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