Validation and Compliance Expert

3 days ago


The Municipal District of Carlow, Ireland eTeam Full time

Required Skills and Qualifications

In order to excel in this role, you will have considerable experience in a comparable role, operating as an individual contributor adding value to the business in a GMP manufacturing setting.

  • Relevant Degree level, Technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, with a proven track record in delivering excellence.
  • Knowledge of CTU equipment qualification.
  • Knowledge of thermal mapping equipment.
  • Thermal mapping skills.
  • Exception / Deviation Management and Change Control.
  • Demonstratable experience of leading technical related projects.
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable.
  • Evidence of continuous professional development is desirable.
  • Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
  • Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile Fill-Finish processes and equipment.
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team-oriented manner.


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