Coordinator Quality Assurance Sterility Assurance In Process -APOTEX INC.-CANADA- Richmond Hill-ON-CANADA;

Review and approve all sterile product production documents according to priorities established by production and the SCORE Planning process. Ensure that the compounding, filling and packaging operations for both non-sterile and sterile product lines follow the established master formula and verify all critical parameters including yields.

2. Report any deviations found during review of sterile product production documents to the Manager, Sterility Assurance. Ensure all corrections are made in the appropriate manner and ensure that all deviations are fully explained and supported by the necessary documentation.

3. Review all in-process testing worksheets for sterile products and ensure tests were performed according to the required procedures/methods and that all results are within established specifications.

4. Perform "Results Recording" in SAP for all applicable sterile product characteristics.

5. Support quality trending for all related operations, including critical EM monitoring and personnel monitoring.

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