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

为什么选择诺华：帮助患者及家属不仅需要创新科学，还需要一支包括你我他在内的充满智慧与激情的团队，大家相互协作、支持与激励。共同实现突破，改变患者的生活。一起共创更好的未来，你准备好了吗？

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薪酬与福利：您可以前往诺华官网了解我们帮助您实现个人与职业发展的举措。

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

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Cost Management

Total Productive Maintenance

Project Execution

Knowledge Of Capa

Risk Management

Agile (Programming Methodology)

Flexibility

Business Networking

Project Engineering

Manufacturing Production

Construction Management

Project Commissioning

Architectural Engineering

Software Development

Including Gdp

Change Control

Computer Science

Installations (Computer Programs)

Knowledge Of Relevant Tools And Systems  

Business Continuity

Root Cause Analysis (RCA)

Aws (Amazon Web Services)

Knowledge Of Gmp

HVAC (Heating Ventilation And Air Conditioning)

General Hse Knowledge