Quality Validation Engineer

Job description

Key Responsibilities Include:

  • Coordinating appropriate assigned elements of the Quality System, ensuring full compliance by all relevant plant personnel with its requirements
  • Coordination and active participation in the validation and quality assurance of site equipment, utilities, processes and software, FDA, European cGMP and GAMP standards
  • Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements
  • Audit the quality system with other personnel where required
  • Assist in the investigation and coordination of customer complaints and assess need for implementation of effective corrective or preventive actions
  • Manage day-to-day CAPA requirements by ensuring timely and effective initiation, investigation, and verification of corrective and preventative actions
  • Measure performance of the Quality System and providing metrics, for inclusion in the management review, monthly reports etc.
  • 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.
  • Ensure compliance to training is maintained
  • Review Lot Records, ensuring documentation is compliant to requirements and complete lot release for shipment
  • Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems at the site

Education & Experience:

  • Degree in Engineering or Science or relevant technical degree
  • Green Belt qualified or demonstrated knowledge of statistics in an industrial environment is desirable
  • 3 years plus experience in the day-to-day operation of the quality system in a highly regulated product/device or pharmaceutical manufacturing environment
  • Minimum 3 years working knowledge of quality systems medical device/pharmaceutical regulations or individual elements within the regulations such as; process validation, design controls, CAPA, auditing, etc., is desirable
  • Experience in an injection moulding or tooling environment is desirable
  • Experience in Computerised Systems Validation is desirable


To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent