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Computer Systems Quality Representative 1285

Cork  

JOB DESCRIPTION

SimoTech requires an experienced Computer Systems Quality Representative for a pharmaceutical client based in Cork. The candidate will be primarily focused on providing Quality leadership, direction and governance for the specific area of responsibility. The successful candidate will be responsible for providing consulting, training and feedback to site and corporate personnel and projects, and lead compliance to computer system quality standards.



Key Responsibilities

  • Maintenance of all aspects of GMP / CSQ compliance for the area(s) of responsibility.
  • Provide guidance, review and approval for all computer related validation documentation.
  • Ensure that existing and new site and QA personnel across the organization are trained on all relevant aspects of computer system quality.
  • Develop common local procedures for Computer Systems.
  • Reports and escalates critical quality issues to the appropriate level of quality management for final resolution.
  • Participate in IT / PA organizations to provide consistency across all Computer Systems areas (e.g., IT, Process Automation, Lab Automation).
  • Lead site computer system maintenance activities and compliance of computer system validation/maintenance activities.
  • Ensure compliance with periodic review, change control, deviation, back up and archive, security and other support processes for systems.


Qualifications

  • Has a degree on BSc, MSc, or PhD in Chemistry, Engineering or related discipline.
  • Quality Systems: Computer Systems (Process Automation, IT and Lab).
  • Systems: DeltaV DCS, Automation Message and Alarm Logger System (AMAL), OSIPI Data Historian System, Biotech Chromatography Computer Systems, Centrifuge PLC Control Systems, Chromatography Column Control Systems, Data Management System, TALAS, Wonderware Historians, MES, GMARS, Quality Docs, Discoverant, Business Object Reports, Darwin, Empower, BOLDER, E-Logs, Desktop Platforms (Windows 10), Site Access Control System, Trackwise.


What SimoTech Can Offer

  • Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
  • Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
  • Opportunity to work with large corporate clients on exciting capital projects.


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