Qualified Person - Dublin.
Our client seeks a Qualified Person.
The 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, component material release, quality performance reporting, and support of investigations.
As a Qualified Person you will be 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.
Interested applicants should have:
• A minimum of a Chemistry, Biology, Engineering or equivalent third level degree qualification.
• A minimum 5 years’ experience in Pharma Quality Assurance and 5 years' QP release experience .
• 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.
• A demonstrated self-starter with a proactive, hands-on approach, possessing excellent interpersonal, decision-making, team work, and communication skills. You should be capable of delivering to tight and often multiple deadlines in a dynamic, challenging work environment.
• You should be ppocess oriented and continuously seek ways to improve current state.