QC Compliance Officer

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 :