업무개요
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1. Tracks deviation related issues and makes final
deviation documents and follows up its corrective & preventive actions if
required. And controls deviation related documents(deviation report, related
SOPs, guidelines)
2. Plans annual audit schedule and proceeds audits according to the schedule.
And prepares audit reports and follows up the findings. And based on audit
report and quality data, prepares supplier evaluation documents.
3. Plans annual training schedule for the production div. and performs basic
GMP trainings for all production div. staffs. Checks training status of each
department and controls training related documents
4. Review production batch records and QC testing records for final product
release and coordinate batch release procedure. And review that QC testing
worksheets including data spread sheets are prepared according to valid
product license and QS/TS
5. Prepares annual product review reports based on the batch records review
data, deviations and changes implemented and checks all the data which
required annual product review
6. Prepares related documents which requested to submit to authorities and
coordinates authority inspections including update of site master files.
7. Initiates and coordinates a stability program according to the respective
SOPs and review stability test data.
8. Checks and confirms that the goods are controlled properly according to
KGSP and premises and equipment in Yongma warehouse are in a good and
hygienic condition
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