泰州市藥城大道88號
*****nbsp;Take****nbsp;part****nbsp;in****nbsp;technology****nbsp;Transfer****nbsp;process****nbsp;for****nbsp;specific****nbsp;Taizhou****nbsp;products****nbsp;being****nbsp;transferred****nbsp;from
other****nbsp;Site****nbsp;to****nbsp;Taizhou****nbsp;site,****nbsp;on****nbsp;the****nbsp;formulation****nbsp;/****nbsp;process****nbsp;from****nbsp;technical****nbsp;perspective-****nbsp;Lead****nbsp;the
receiving****nbsp;site****nbsp;activities****nbsp;to****nbsp;enable****nbsp;successful****nbsp;TT****nbsp;these****nbsp;may****nbsp;include****nbsp;TORA,****nbsp;establishment****nbsp;trials,
validation****nbsp;manufacture,****nbsp;stability****nbsp;batch****nbsp;generation****nbsp;and****nbsp;documentation****nbsp;to****nbsp;support****nbsp;the****nbsp;process
*****nbsp;Be****nbsp;responsible****nbsp;to****nbsp;the****nbsp;cleaning****nbsp;validation****nbsp;procedure,****nbsp;and****nbsp;execution****nbsp;of****nbsp;miscellaneous****nbsp;cleaning
validation****nbsp;studies****nbsp;including****nbsp;Process****nbsp;equipment****nbsp;and****nbsp;Packaging****nbsp;equipment,****nbsp;if****nbsp;applicable
*****nbsp;Supportive****nbsp;to****nbsp;the****nbsp;equipment****nbsp;and****nbsp;clean****nbsp;utilities****nbsp;commissioning-****nbsp;as****nbsp;part****nbsp;of****nbsp;the****nbsp;project****nbsp;effort,****nbsp;it
may****nbsp;include****nbsp;process****nbsp;parameter****nbsp;setting****nbsp;up****nbsp;for****nbsp;wet****nbsp;granulation,****nbsp;tableting****nbsp;process****nbsp;until****nbsp;coating,
and****nbsp;completion****nbsp;of****nbsp;process****nbsp;validation****nbsp;until****nbsp;the****nbsp;success****nbsp;of****nbsp;the****nbsp;GMP****nbsp;inspection****nbsp;and****nbsp;license
*****nbsp;Ensure****nbsp;the****nbsp;regulatory/GMP****nbsp;compliance****nbsp;on****nbsp;the****nbsp;process/technical****nbsp;dossier,****nbsp;and****nbsp;relative
coordination****nbsp;work****nbsp;if****nbsp;required
*****nbsp;Also,****nbsp;as****nbsp;a****nbsp;receiving****nbsp;site,****nbsp;will****nbsp;take****nbsp;part****nbsp;in****nbsp;the****nbsp;assessment****nbsp;of****nbsp;NEW****nbsp;product****nbsp;feasibility****nbsp;of****nbsp;Taizhou
facility,****nbsp;and****nbsp;their****nbsp;manufacturability****nbsp;in****nbsp;Taizhou****nbsp;site****nbsp;and****nbsp;ensure****nbsp;products****nbsp;can****nbsp;be****nbsp;produced****nbsp;in
compliance****nbsp;with****nbsp;AZ****nbsp;quality****nbsp;standard****nbsp;and****nbsp;site****nbsp;Lean****nbsp;requirement
江蘇省 - 泰州市
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