Collins McNicholas

Essential Skills, Experience and Competencies:

  • Comprehensive understanding of Validation principles and practices.

  • Comprehensive understanding of Risked Based Verification and ASTM-E2500-13 and relevant EU/FDA regulations.

  • Understanding of Process Validation, Computer system Validation, SCADA systems, CPV, Sterilization, Packaging systems and related technologies.

  • A good understanding of current data integrity expectations would be an advantage.

  • Ability to respond to emergency changes that may present themselves while maintaining high levels of GxP throughout the validation effort.

  • Project Management experience would be an advantage.

Education and Experience

  • Bachelor’s degree in engineering or equivalent.
  • Minimum 7 years’ experience in the Validation/CQV industry.

  • A proven track record that demonstrates the ability to work without direct supervision whilst maintaining adherence to project delivery is fundamental to the role.

  • Good interpersonal and communication skills essential for working across multi-functional teams. 

  • Comfortable to take on large / complex projects containing multiple modules and multiple Vendors with interlinked systems.

For a confidential discussion and more information on the role, please contact Edyta Fleming on 091706721 or email edyta.fleming@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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