Collins McNicholas

Computer Systems Validation (CSV) Quality Engineer

As part of the Quality Assurance team on a multinational pharma project we require a CSV Engineer to ensure that product manufactured at the site including new product introductions complies with approved specifications and that activities at the site comply with current good manufacturing practice and Regulatory Agency requirements.

Key responsibilities;

  • Development and execution of the qualification for Information Systems and GxP software systems.
  • Development of life cycle documents necessary to address the validation lifecycle for Information Systems and GxP software systems (Planning, Risk, Implementation, and maintenance of the validated state).
  • Ensure that Appropriate Systems are in place to evaluate changes to Validated/Qualified Systems from a Computer Systems/Software Validation perspective to ensure their continued validated/qualified state.
  • Review/Approval of all Computer Systems/Software Validation Documentation.
  • Generate 21 CFR Part11 and Annex 11 Assessments for CSV Project s. Ensure the site is in compliance with these standards.
  • Identify GAPs in Project delivery and report to Management
  • Participate as required in project activities.
  • Report and help resolve issues with respect to CSV Projects
  • Maintain and support proactive communications regarding automation related activities to ensure conformance and maintain related work schedules.
  • Performs effective document review to support Automation Compliance activities.
  • Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training.
  • Ensure Management is kept informed of all system failures to ensure corrective/preventive action and product containment is taken where necessary.
  • Ensure Quality System documentation is thorough, complete, and compliant including documents for new products.
  • Ensure compliance to training requirements is maintained.
  • Represent Quality at new product project meetings

Requirements:

Bachelor’s degree in relevant Science or Engineering, plus minimum of 3 years of experience working in a highly regulated manufacturing environment.

Preferred Technical Skills:

  • Experience of validating/testing computer systems together with good knowledge of compliance good practise (i.e. GAMP5, 21 CFR Part 11, EU Annex 11 & GxPs).
  • Experience of production and laboratory systems beneficial. Knowledge around MES, SAP, Plant Data Historian, Metrology Instruments and associated software.
  • Experience of IT infrastructure qualification beneficial.
  • Experience with computer controlled equipment automation systems and Human Machine interphases beneficial

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For a confidential discussion and more information on the role, please contact Davin Ferguson on 0719140251 or email davin.ferguson@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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