To execute and report on Cleanroom Environmental Monitoring, Water for Injection sampling & testing. Support laboratory housekeeping and microbiological testing of raw materials, in process, bulk drug substance, final products and stability products. Role Conduct Environmental Monitoring and Water for Injection sampling/testing as directed by the line manager or delegate Support Microbiological testing of raw materials, in process, bulk drug substance, final products and stability products to GMP as directed by the line manager or delegate and inform relevant personnel in a timely manner of any failure or atypical result. Report and check data in compliance with Data Integrity requirements. Carry out general stock orders/checks/updates for raw materials and consumables, support maintenance and housekeeping of equipment and laboratories. Support calibration of equipment and instruments used to perform QC Micro testing and inform relevant personnel in a timely manner of any failure of calibration. Assist in equipment periodic reviews, monitoring and maintaining calibration status of equipment within the Quality Control department Take part in deviations, investigations and laboratory investigations as directed by line manager or delegate. Assist in updates of SOPs, instructions and protocols and other Quality Control documentation 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 Be available to provide cover for other departments within the organisation Be available to undertake any other duties as requested by the line manager in accordance with Company requirements
QC Micro Technician (shifts)
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