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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Associate Quality Specialist


Reference:RK26071 Location: Tipperary
Qualification:DegreeExperience:2-3 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Analyst

Associate Quality Specialist
Onsite
RK26071
Contract 11 months
Tipperary



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



Key Responsibilities:

  • Participate as functional expert in the cross functional team that manages production right first time.
  • Review and approve batch, cleaning and testing documentation.
  • Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified.
  • Provide support to deviation investigations and process performance monitoring.
  • Perform trending on deviations raised as required to identify improvement initiatives.
  • Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed.
  • Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments.
  • Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes.
  • Ensure changes controls raised are documented, assessed and completed.
  • Prepare Annual Process and System Reviews.
  • Act as lead/team auditor to support the internal GMP walkdown and scheduled audits.
  • Participate in the generation and communication of quality metrics.
  • Creation, review and approval of quality procedures as required.


Education and Experience:
  • Degree or post-graduate qualification in Science, Pharmacy or equivalent.
  • Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
  • Spray drying experience desirable.
  • Knowledge and demonstrated expertise in Lean / Continuous Improvement.
  • Experience and knowledge of GMP Requirements for Electronic /paper free operations.
  • Experience in High potency manufacturing desirable.


If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.