QC Compliance Officer

apartmentGreys Personnel placeGermiston calendar_month 

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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