Quality Engineer

Job description

My client a Cork based pharmaceutical company currently has a vacancy for a Quality Engineer 

Key responsibilities will include the following:

  • Supervision of Junior Quality personnel.
  • Drive and implement process improvements to ensure predictable processes across all lines.
  • Ensure all process variables and their interactions are adequately defined.
  • Ensure all failure modes in process are identified & addressed. (e.g. Use of DOE studies, FMEA's).
  • Drive and implement plant wide quality system improvements.
  • Ensure Regulatory compliance in area of responsibility to cGMP's of all regulated agencies (e.g. FDA and TUV)
  • Provide functional expertise to other support functions on quality related issues.
  • Identification and implementation of appropriate statistical techniques to monitor process performance.
  • Approval of change requests for product, process and quality system changes.
  • Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
  • Validation: Define process, product and test method validation requirements,
  •  Preparation and approval of Master Validation Plans and protocols.
  • Compilation of required Regulatory documentation 
  • Educational Requirements:
  • - Minimum qualification: BSC/BEng degree.
  • - Minimum of 2/3 years experience in a QA role.
  • - Knowledge of GMP regulated environment and experience in a similar role would be an advantage.
  • For more information please call Colin by E-Mail