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.
- 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.
- Check and review data to ensure compliance with Data Integrity requirements.
- Participate in stability study activities, manage storage of in-process and final samples, and oversee retention samples.
- Maintain adequate stock control of PPE, consumables, and materials.
- Assist in coordinating incoming deliveries and dispatches.
- Arrange subcontracting of QC testing and dispatches with approved suppliers as appropriate.
- Assist in document writing, including procedures, investigations, and deviations, after completing relevant training.
- Ensure laboratory areas and surrounding QC facilities are cleaned and maintained according to housekeeping procedures and remain inspection-ready.
- Manage storage units, fridges, freezers, and incubators, ensuring they are defrosted and cleaned as per procedures, and monitor/report temperature excursions promptly.
- Perform general maintenance and calibration of testing equipment and notify relevant personnel of any calibration failures.
- Contribute to audit readiness and continuous improvement initiatives within the department and site.
- Maintain and update Quality Control information systems.
- Stay informed about relevant regulatory requirements for GMP, safety, and environmental policies to perform the role effectively.
- Provide coverage for other departments within the organization as needed.
- Perform any other duties assigned by the QC Manager in line with company requirements.
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Contact Detail:
JR United Kingdom Recruiting Team