Job Description
Execute defined Quality Control department activities including housekeeping, testing of raw materials, in process products and where appropriate, bulk drug substance, final products and stability products according to defined procedures and best cGMP work practice, Quality standards and metrics.
Role
* Perform testing activities by following procedures and report results in timely manner of raw materials and in process samples and where assigned by the Team Leader, of bulk drug substances, final products and stability products applying cGMP and quality standards.
* Check and review data in compliance with Data Integrity requirement.
* Perform any stability study programme activities, storage of in process and final samples and retention samples management.
* Ensure that PPE, consumable and material are available by maintaining adequate stock control.
* Assist in coordination of incoming deliveries and dispatches.
* Arrange subcontract of QC testing and dispatches to approved suppliers as appropriate.
* Assist in document writing including procedure, investigation and deviation where training has been completed.
* Ensure that all laboratory areas and surrounding QC facilities are cleaned and maintained in accordance with housekeeping procedure and processes and remain at an inspection ready state.
* Ensure that all storage units, fridges, freezers and incubators are defrost and cleaned as defined per procedure and monitor and report any temperature excursion in a timely manner.
* Carry out general maintenance and calibration of equipment used to perform testing and inform relevant personnel in a timely manner of any failure of calibration.
* Actively contribute to department and site audit readiness requirements including any continuous improvement initiatives.
* Maintain Quality Control information systems.
* Maintain a technical ability, knowledge and understanding of relevant regulatory requirements for GMP, safety and environmental policies required in order to perform role as QC Technician.
* Be available to provide cover for other departments within the organisation as required.
* Be available to undertake any other duties as requested by the QC Manager in accordance with Company requirements.