公司簡介
諾華中國
所屬團隊
職位屬性
- 招聘類型：社招
- 工作性質(zhì)：全職
職位描述
Responsible for defining, planning, executing and reporting on Commissioning & Qualification for CAPEX projects and/or routine manufacturing operation ensuring GxP compliance of plant/facilities/equipment.
Strategy & Organizational Development:
?Support internal and external audits
?Create and maintain GOPs and provide standard training
?Implement GOPs
?If needed, create regional / site SOPs & templates
?C&Q related IT system owner for Haiyan Site
Project Engineering & Control:
?Develop Project schedule
?Perform project risk assessment
?Identify technical solutions
?Prepare project quality plan
?Develop project document management and archiving concept
?Perform project reviews (e.g. Technical Quality Review (TQR), constructability, sustainability, HSE)
?Develop project commissioning plan / strategy
?Establish project change management and manage changes
?Develop project execution plan (e.g. C&Q)
?Prepare / execute Project Health & Safety Risk Assessments (Equipment / Process)
?Expedite and manage project vendors / contractors / 3rd parties in project
?Develop test specification / plan for commissioning & qualification in projects
?Perform new equipment FAT / SAT / inspections in project
?Implement and monitor construction contractor safety and inspection plan
?Execute work orders for projects as per method statement
?Perform commissioning activities
?Manage project deficiencies and deviations
?Perform provisional and final project handover
Maintenance & Calibration:
?Plan initial calibrations
?Coordinate maintenance / calibration activities
?Plan resources for maintenance / calibration
?Allocate work for maintenance / calibration to technicians
?Identify spare parts for maintenance and maintain pick-lists
?Establish Master Instrument Inventory (MII) and Master Equipment Inventory (MEI)
?Get permits for maintenance / calibration / projects
?Execute work orders for maintenance / calibration as per method statement / procedure
?Provide front line support for technicians
?Supervise maintenance and calibration works
?Assess quality impact and release after maintenance work
?Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request
?Execute change requests
?Investigate deviations (root cause analysis)
?Create / maintain / verify engineering documents (protocols, drawings, lists, schedules, diagrams, layouts, calculations, datasheets)
(Re-) Qualification:
?Develop qualification plan
?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
?Develop periodic requalification plan
?Execute periodic requalification plan
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任職條件
Project Commissioning
Change Control
Aws (Amazon Web Services)
Manufacturing Production
Knowledge Of Relevant Tools And Systems??
Cost Management
Project Execution
Business Networking
Business Continuity
General Hse Knowledge
Risk Management
Project Engineering
Installations (Computer Programs)
Software Development
Knowledge Of Gmp
Knowledge Of Capa
Agile (Programming Methodology)
Architectural Engineering
Total Productive Maintenance
Including Gdp
Computer Science
HVAC (Heating Ventilation And Air Conditioning)
Root Cause Analysis (RCA)
Construction Management
Flexibility
職位要求
- 學(xué)歷要求：無
- 工作經(jīng)驗：經(jīng)驗不限
- 外語要求：不需要