Roles & Responsibilities:
- Previous experience as a Quality Engineer, to include:
- Putting together a Risk Assessment in Pharma Manufacturing and understanding the concept of assessing machinery for potential failure modes and quality issues.
- Working with automated pharmaceutical manufacturing equipment through commissioning and qualification or other practical hands-on experience.
- Knowing what a human machine interface is, what a PLC controlled system looks like, how an operator would log into a machine to use it, etc.
- Investigation of deviations and CAPAs.
- Writing reports and procedures.