Connecting...

QA Specialist (Changeover)

Job description

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

This is a contract role with a stronh chance of permanency.

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

Role

  • 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.

Education

  • 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.
  • At least 2 years relevant work experience.
  • 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 codonnell@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.