Qualified Person (QP)- Pharmaceutical MNC- Dublin
QP required to join a busy Quality Release department, within a pharmaceutical manufacturing site.
The ideal candidate will have strong experience in dealing with release and simple Quality processes and will have a solid background in compliance.
- The Qualified Person's, role involves responsibility for a range of GMP and product release support activities which can include Quality batch documentation review and control, review and approval of controlled documents including LPR's and SOP's, component material release, quality performance reporting, and support of investigations.
- Qualified Persons are expected to support and deliver continuous improvements to remove waste and non-value added activities and to employ problem solving tools including root cause analyses and CAPA identification.
- They make sure that everything is running smoothly and efficiently. It's about focusing on patients, getting the basics right and challenging the status quo.
Education and Experience:
- Science, Engineering or equivalent third level degree qualification.
- 5 years'+ experience in Pharma Quality Assurance and 5 years QP release.
- Strong understanding of pharmaceutical quality processes and systems, manufacturing processes and other support/control systems is desirable.
- Knowledge and experience working with Competent Authorities on Quality Defects, Recalls.
- People management experience and openness to taking on a level of coaching with the Release team.
- Capable of delivering to tight and often multiple deadlines in a dynamic, challenging work environment.
- Lean Improvment experience
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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