Develop, manage, and implement quality principles to ensure effective compliance of the affiliate quality system with AbbVie policies, processes and procedures and all applicable regulations and industry standards, including establishment and maintenance of local procedures, work instructions, records, and all applicable quality system documents.
Review and approve GMP documents, including SOPs, protocols, reports, and change controls, to ensure compliance with Pfizer global and local documents.
Support end-to-end CQV lifecycle for process, utility, and support systems e.g. bioreactors, chromatography skids, filtration units, CIP/SIP, WFI, HVAC, autoclaves, and clean utilities.
Support end-to-end CQV lifecycle for process, utility, and support systems e.g. bioreactors, chromatography skids, filtration units, CIP/SIP, WFI, HVAC, autoclaves, and clean utilities.