Description
We currently require a QA Specialist for an 11 month contract, based in Central Ireland. The QA Specialist shall carry out most of their duties in the within an integrated quality team.Key Responsibilities:
- Provide quality oversight and expertise as required for manufacturing operations.
- Review of all manufacturing batch documentation including electronic batch records, real time reports, master data.
- Responsible for supporting deviation and atypical close out and initiating/following up on corrective and preventative actions using the site SAP system as a tool.
- Assist in the proactive evaluation of site compliance against emerging regulatory trends.
- Drive continuous improvement by leading and active participation in system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.
- Manage root cause analysis.
- Review and approval of validation documents, change controls, SOP's for the IPT department.
- Leading out of specification investigation.
Skills and Experience:
- Relevant Degree level qualification or equivalent.
- Experience of working within a manufacturing facility (IMB and FDA approve).
- Expertise in Aseptic and Vial or Syringe activities
- Experience in batch review, electronic batch record would be an advantage.
- Previous use of SAP/Trackwise would be beneficial.
- Experience of preparing for and participating in regulatory audits in particular IMB/FDA.
For more information about this fantastic opportunity, please apply today.