The Manufacturing Operator performs functions related to the manufacture of drug products, such as setting-up, cleaning, operating, and maintaining equipment. The role assists in troubleshooting process and equipment issues and observes established escalation paths.
- The Manufacturing Operator will support and adhere to established manufacturing scheduling processes and production targets.
- Handle raw materials and/or intermediate or finished products according to applicable SOPs.
- Operate pharmaceutical production equipment, for new and existing technologies, in strict accordance with production batch records, SOPs, and cGMPs. This includes Gowning correctly and wearing of assigned PPE, performing start-up and testing of manufacturing equipment, operating and monitoring equipment, performing in process equipment tests, observing varying conditions and adjusting equipment controls as required.
- Perform AQL sampling.
- Complete all required production data entries and calculations for manufactured batches on the BMR/PI Sheet/SIC logs with detail and accuracy in real time.
- Observe established escalation process for issues impacting established production-related Service Level Agreements (SLAs) and/or fulfilment of production goals.
- The Manufacturing Operator will perform master cleans and surface cleans of manufacturing equipment and production areas according to established SOPs and SLAs.
The next Manufacturing Operator should have a Leaving Certificate as minimum with exposure to pharmaceutical manufacturing equipment or equivalent. Experience with OSD operations is required
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