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.

Responsibilities:
• 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 William.cunnage@peglobal.net 
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

By continuing to use the site, you agree to the use of cookies. More Information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close