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 email@example.com