Engineering & Electronics

QA Specialist

  • Contract
  • Remote
  • Dublin West
  • 41950725

The Role:
PE Global are recruiting for a QA Specialist who will perform an integral role in the Dublin team.

• Provide QA support for Risk-Based Verification (RBV) and Computer Systems Validation (CSV) activities in the capacity of Quality Assurance Subject Matter Expert.
• Review and approval equipment/utilities verification documentation from design to post execution.
• Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
• Review and approve Validation protocols / reports as required.
• Provide quality support for serialization of Finished Products
• Support the vendor quality management program including generation and review of Quality Agreements
• Provide oversight to continuous quality system improvements and support implementation of improvements at College Park in compliance, Preventive Maintenance, Deviation Management and the Change Control Programs.
• Provide QA and compliance support to projects, including NPIs, for Alexion Dublin packaging activities.
• Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
• Provide Quality input, oversight and guidance to Alexion deviations and investigations to ensure robust root cause analysis/CAPA definition and timely closure as per Alexion SOPs and QMS.
• Provide Quality input, oversight and guidance to change controls, supporting risk assessments as required.
• Review and approval of functional area documentation (SOPs, Packaging Instructions, Work Instructions, technical protocols and reports)
• Leading actions assigned to College Park from complaints process
• Define and report standard quality KPIs with recommendation for actions for improvement in relation to College park operations.
• Supporting ‘right first time’ and continuous improvement from a systematic and compliance perspective

Education and Experience:

  • Proven track-record in delivering results in a world-class supply organisation.
  • Innovative thinker, with excellent decision-making and problem-solving skills.
  • Experience of working in a cross functional environment.
  • Knowledge of and experience in applying Six Sigma and Lean methodologies 
  • Experience in Compliance systems such as IPI, SAP etc a distinct advantage
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
    Report, standards, policy writing skills required
  • Proficiency in Microsoft Office and job related computer applications required

Interested candidates should submit an updated CV.

Please click the link below to apply, call William Cunnage on +353 21 4297900 or alternatively send an up to date CV to 
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

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