Operations Support Team Lead, Drug Product Operations

7 days ago


Singapore WuXi Biologics Full time

Description Operations Support Team Lead, Drug Product Operations Responsibilities Support the installation and qualification of new manufacturing equipment as required from Operational Support related roles. Develop and implement operational procedures, including SOPs, master batch records, and work instructions, as required Establish service provider, manage contractors and schedules with contractors (e.g., cleaning/disinfecting, gown laundry, etc.). Hire, train, and manage operational staffs required to support site readiness. Develop, manage, and track training and qualification of manufacturing operation staffs. Coordinate and train as required before systems go-live. Ensure adherence to quality standards and client requirements for aseptic processes as required during the initial site startup. Work with Manufacturing Science & Technology (MSAT), Validation, Quality, and QC teams to ensure applicable procedures are developed and personnel are trained for new product introductions. Stay informed on global regulatory requirements (FDA, EMA, PIC/S, ICH) for aseptic manufacturing and product introduction, and remain up to date on current Good Manufacturing Practices (cGMP). Demonstrate mastery of Quality Management System (QMS) production support systems such as Change Control, Deviation, CAPA, and SAP. Interface with clients for technology



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