摘要
Responsible for execution of Utility related maintenance & calibration activities and commissioning activities for projects in RLT CN Project. Ensure technical in depth understanding on site utility and facility to ensure the capability of problem solving and supporting on routine operations. Might provide on-shift support to ensure a reliable utility performance to support non-stop GMP environment and routine RLT products production.
About the Role
Strategy & Organizational Development
Support internal and external audits
Maintenance & Calibration on Utilities and other Technical Supporting Facilities
Prepare tools, spare parts etc. for maintenance / calibration Identify spare parts for maintenance and maintain pick-lists Get permits for maintenance / calibration / projects Execute work orders for maintenance / calibration as per method statement / procedure Supervise maintenance / calibration work as Subject Matter Expert (SME) Update CMMS after maintenance / calibration completion Document execution of calibration Manage stores for spare parts (good receipt, incoming inspection, delivery to work area, make parts for quick repairs and improvements) Project Engineering & Control
Might provide on shifts support to ensure a reliable machine performance for technical transfer and future site operations per business needs. Prepare, review and approve drawings, lists, schedules, diagrams, layouts, calculations and datasheets in project Collaborate with project vendors / contractors / 3rd parties in project Perform or support commissioning & qualification in projects Perform new equipment FAT / SAT / inspections in project in relation to utility Conduct problem solving for project deficiencies or deviations. (Re-) Qualification
Perform GMP risk assessments (incl. Sensors SRA) Create DQ, IQ and OQ protocols Execute DQ, IQ and OQ Create DQ, IQ and OQ reports Provide technical trouble shooting during PQ and validation
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Business Unit
Innovative Medicines
站点
Haiyan (Zhejiang Province)
Company / Legal Entity
CN27 (FCRS = CN027) Novartis Pharmaceutical Technology Zhejiang Co., Ltd.
Functional Area
Technical Operations
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