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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

Knowledge Of Gmp

Project Engineering

Construction Management

Computer Science

Aws (Amazon Web Services)

Project Execution

Business Networking

Agile (Programming Methodology)

HVAC (Heating Ventilation And Air Conditioning)

Risk Management

Knowledge Of Capa

Project Commissioning

Business Continuity

Software Development

Root Cause Analysis (RCA)

Change Control

Flexibility

General Hse Knowledge

Cost Management

Architectural Engineering

Installations (Computer Programs)

Knowledge Of Relevant Tools And Systems??

Including Gdp

Manufacturing Production

Total Productive Maintenance