QA Specialist (Changeover)

Job description

My client a Cork based pharmaceutical company require a QA Specialist (Changeover).

Key duties in this role include (but not limited to) :


  • Co-ordinate the manufacturing activities in a multi-product manufacturing facility.

  • Ownership of Post-manufacturing to the required safety standard & delivering audit readiness

  • Provide process technical support in order to sustain & improve the changeover processes on site

  • Lead all GMP aspects of the postMI, ensuring documentation is in place prior to the start of the changeover.

  • Ensure 100% Manufacturing Right First time during the post MI. 

  • Using Right First Time tools, trouble-shoot and provide sustainable solutions for root cause problems.

  • Work closely with the Operations, Safety, Engineering, Quality Operations and Value Stream Teams.

  • Ensure change-overs are executed with zero SIIs and zero defects

  • Identify hazards, assess risk & incorporates recommendations into designs of post manufacture.

  • Effectively use the site business processes to support & to monitor post manufacturing.

  • Comfortable with change control, deviations, 6 sigma method investigations.

  • Work with the Change-over team in leading in the implementation of key change-over projects.

  • Focus on Continious Imporovement & reducing the site change-over time.

  • Align change-overs to Standard Work Plans and lead other Lean initiatives.


  • A relevant 3rd Level qualification (Degree/Diploma) and significant experience in a pharmaceutical environment.
  • A demonstrated ability to proactively problem solve solutions to Engineering and Quality scenarios.
  • Excellent people and communication skills working in a cross functional team environment.
  • A proven knowledge of GMP procedures and the requirements of change controls & SOP's
  • Demonstrated applications of Lean and Six Sigma tools will be an advantage.

For more information please mail