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- 职位介绍
- * Take part in technology Transfer process for specific Taizhou products being transferred from other Site to Taizhou site, on the formulation / process from technical perspective- Lead the receiving site activities to enable successful TT these may include TORA, establishment trials, validation manufacture, stability batch generation and documentation to support the process * Be responsible to the cleaning validation procedure, and execution of miscellaneous cleaning validation studies including Process equipment and Packaging equipment, if applicable * Supportive to the equipment and clean utilities commissioning- as part of the project effort, it may include process parameter setting up for wet granulation, tableting process until coating, and completion of process validation until the success of the GMP inspection and license * Ensure the regulatory/GMP compliance on the process/technical dossier, and relative coordination work if required * Also, as a receiving site, will take part in the assessment of NEW product feasibility of Taizhou facility, and their manufacturability in Taizhou site and ensure products can be produced in compliance with AZ quality standard and site Lean requirement
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