Role
Execute defined Quality Control department activities including housekeeping, testing of raw materials, in-process products, and, where appropriate, bulk drug substances, final products, and stability products according to defined procedures, best cGMP practices, quality standards, and metrics.
1. Perform testing activities by following procedures and report results in a timely manner for raw materials, in-process samples, and, when assigned by the Team Leader, for bulk drug substances, final products, and stability products, applying cGMP and quality standards.
2. Check and review data to ensure compliance with Data Integrity requirements.
3. Participate in stability study activities, manage storage of in-process and final samples, and oversee retention samples.
4. Maintain adequate stock control of PPE, consumables, and materials.
5. Assist in coordinating incoming deliveries and dispatches.
6. Arrange subcontracting of QC testing and dispatches with approved suppliers as appropriate.
7. Assist in document writing, including procedures, investigations, and deviations, after completing relevant training.
8. Ensure laboratory areas and surrounding QC facilities are cleaned and maintained according to housekeeping procedures and remain inspection-ready.
9. Manage storage units, fridges, freezers, and incubators, ensuring they are defrosted and cleaned as per procedures, and monitor/report temperature excursions promptly.
10. Perform general maintenance and calibration of testing equipment and notify relevant personnel of any calibration failures.
11. Contribute to audit readiness and continuous improvement initiatives within the department and site.
12. Maintain and update Quality Control information systems.
13. Stay informed about relevant regulatory requirements for GMP, safety, and environmental policies to perform the role effectively.
14. Provide coverage for other departments within the organization as needed.
15. Perform any other duties assigned by the QC Manager in line with company requirements.
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