1. Ensure that batch documents/Analytical/Validation documents required by QA to be soft archived, scanned and retained on digital storage media.
2. Scan MBRs prior to release for review & update tracker.
3. Ensure that the soft data archive is maintained & structured.
4. Update and maintain tracker log ensuring correctness of data entry.
5. Keep appropriate records as required.
6. To ensure that staff employed in the areas are trained & supervised as required.
7. Participate and facilitate in self-inspections, internal and other audits as required.
8. Physical maintenance of artwork files.
9. Control of Master and controlled stamps.
10. To ensure compliance to GMP requirements and Regulatory updates.
11. Update and maintain training records.
12. Adherence to H&S requirements.
13. Perform any other responsibilities assigned by management.
Support QA staff for various activities including documentation
In addition to your main duties you will be required to carry out such other duties consistent with your position within the Company as maybe required from time to time.
The ideal candidate: