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
How to apply :